• Acerca de la base de datos
  • ¿Cómo usar la IMDD?
  • Descargar la data
  • Preguntas frecuentes
  • Créditos
Vista de la lista Vista de las tarjetas
  • Dispositivo 254
  • Fabricante 101
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Device Recall Chlamydia Trachomatis IgG ELISA 96 Well Kit
  • Tipo de evento
    Recall
  • ID del evento
    50691
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0987-2010
  • Fecha de inicio del evento
    2008-08-27
  • Fecha de publicación del evento
    2010-03-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76367
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    C. Trachomatis (Chlamydia Group) - Product Code MGM
  • Causa
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Acción
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
Retiro De Equipo (Recall) de Device Recall Chlamydia Trachomatis IgM ELISA 96 Well Kit
  • Tipo de evento
    Recall
  • ID del evento
    50691
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0988-2010
  • Fecha de inicio del evento
    2008-08-27
  • Fecha de publicación del evento
    2010-03-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76368
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    C. Trachomatis (Chlamydia Group) - Product Code MGM
  • Causa
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Acción
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
Retiro De Equipo (Recall) de Device Recall Chlamydia Trachomatis IgA ELISA 96 Well Kit
  • Tipo de evento
    Recall
  • ID del evento
    50691
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0989-2010
  • Fecha de inicio del evento
    2008-08-27
  • Fecha de publicación del evento
    2010-03-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76369
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    C. Trachomatis (Chlamydia Group) - Product Code MGM
  • Causa
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Acción
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
Retiro De Equipo (Recall) de Device Recall dsDNA IgG ELISA 96 Well Kit
  • Tipo de evento
    Recall
  • ID del evento
    50691
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0990-2010
  • Fecha de inicio del evento
    2008-08-27
  • Fecha de publicación del evento
    2010-03-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76370
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control - Product Code LRM
  • Causa
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Acción
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
Retiro De Equipo (Recall) de Kendall
  • Tipo de evento
    Recall
  • ID del evento
    30196
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0094-05
  • Fecha de inicio del evento
    2004-10-08
  • Fecha de publicación del evento
    2004-11-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35383
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Needle, Hypodermic, Single Lumen - Product Code FMI
  • Causa
    Needle cannula may separate from the hub during use.
  • Acción
    Recall letters requesting product return were mailed to all customers on October 8, 2004
Retiro De Equipo (Recall) de Device Recall Dengue IgG ELISA 96 Well Kit
  • Tipo de evento
    Recall
  • ID del evento
    50691
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0991-2010
  • Fecha de inicio del evento
    2008-08-27
  • Fecha de publicación del evento
    2010-03-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76371
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies - Product Code NWY
  • Causa
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Acción
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
Retiro De Equipo (Recall) de Device Recall Dengue IgM ELISA 96 Well Kit
  • Tipo de evento
    Recall
  • ID del evento
    50691
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0992-2010
  • Fecha de inicio del evento
    2008-08-27
  • Fecha de publicación del evento
    2010-03-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76372
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies - Product Code NWY
  • Causa
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Acción
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
Retiro De Equipo (Recall) de Device Recall EBV VCA IgG ELISA 96 Well Kit
  • Tipo de evento
    Recall
  • ID del evento
    50691
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0993-2010
  • Fecha de inicio del evento
    2008-08-27
  • Fecha de publicación del evento
    2010-03-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76373
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. - Product Code LJZ
  • Causa
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Acción
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
Retiro De Equipo (Recall) de Device Recall EBV VCA IgM ELISA 96 Well Kit
  • Tipo de evento
    Recall
  • ID del evento
    50691
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0994-2010
  • Fecha de inicio del evento
    2008-08-27
  • Fecha de publicación del evento
    2010-03-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76374
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Epstein-Barr Virus, Other - Product Code LSE
  • Causa
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Acción
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
Retiro De Equipo (Recall) de Kendall
  • Tipo de evento
    Recall
  • ID del evento
    30196
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0095-05
  • Fecha de inicio del evento
    2004-10-08
  • Fecha de publicación del evento
    2004-11-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35384
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Needle, Hypodermic, Single Lumen - Product Code FMI
  • Causa
    Needle cannula may separate from the hub during use.
  • Acción
    Recall letters requesting product return were mailed to all customers on October 8, 2004
Retiro De Equipo (Recall) de Device Recall H. Pylori IgA ELISA 96 Well Kit
  • Tipo de evento
    Recall
  • ID del evento
    50691
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0995-2010
  • Fecha de inicio del evento
    2008-08-27
  • Fecha de publicación del evento
    2010-03-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76375
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Helicobacter Pylori - Product Code LYR
  • Causa
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Acción
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
Retiro De Equipo (Recall) de Device Recall H. Pylori IgM ELISA 96 Well Kit
  • Tipo de evento
    Recall
  • ID del evento
    50691
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0996-2010
  • Fecha de inicio del evento
    2008-08-27
  • Fecha de publicación del evento
    2010-03-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76376
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Helicobacter Pylori - Product Code LYR
  • Causa
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Acción
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
Retiro De Equipo (Recall) de Device Recall Mycoplasma IgG ELISA 96 Well Kit
  • Tipo de evento
    Recall
  • ID del evento
    50691
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0997-2010
  • Fecha de inicio del evento
    2008-08-27
  • Fecha de publicación del evento
    2010-03-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76377
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. - Product Code LJZ
  • Causa
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Acción
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
Retiro De Equipo (Recall) de Device Recall Mycoplasma IgM ELISA 96 Well K
  • Tipo de evento
    Recall
  • ID del evento
    50691
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0998-2010
  • Fecha de inicio del evento
    2008-08-27
  • Fecha de publicación del evento
    2010-03-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76378
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. - Product Code LJZ
  • Causa
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Acción
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
Retiro De Equipo (Recall) de Kendall
  • Tipo de evento
    Recall
  • ID del evento
    30196
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0096-05
  • Fecha de inicio del evento
    2004-10-08
  • Fecha de publicación del evento
    2004-11-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35385
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Needle, Hypodermic, Single Lumen - Product Code FMI
  • Causa
    Needle cannula may separate from the hub during use.
  • Acción
    Recall letters requesting product return were mailed to all customers on October 8, 2004
Retiro De Equipo (Recall) de Device Recall Mumps IgM ELISA 96 Well Kit
  • Tipo de evento
    Recall
  • ID del evento
    50691
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0999-2010
  • Fecha de inicio del evento
    2008-08-27
  • Fecha de publicación del evento
    2010-03-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76379
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Enzyme Linked Immunoabsorbent Assay, Mumps Virus - Product Code LJY
  • Causa
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Acción
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
Retiro De Equipo (Recall) de Device Recall Measles IgG ELISA 96 Well Kit
  • Tipo de evento
    Recall
  • ID del evento
    50691
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1000-2010
  • Fecha de inicio del evento
    2008-08-27
  • Fecha de publicación del evento
    2010-03-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76380
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Enzyme Linked Immunoabsorbent Assay, Rubeola Igg - Product Code LJB
  • Causa
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Acción
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
Retiro De Equipo (Recall) de Device Recall Measles IgM ELISA 96 Well Kit
  • Tipo de evento
    Recall
  • ID del evento
    50691
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1001-2010
  • Fecha de inicio del evento
    2008-08-27
  • Fecha de publicación del evento
    2010-03-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76381
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Enzyme Linked Immunoabsorbent Assay, Rubeola Igg - Product Code LJB
  • Causa
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Acción
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
Retiro De Equipo (Recall) de Device Recall Toxoplasma IgM ELISA 96 Well Kit
  • Tipo de evento
    Recall
  • ID del evento
    50691
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1002-2012
  • Fecha de inicio del evento
    2008-08-27
  • Fecha de publicación del evento
    2010-03-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76382
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii - Product Code LGD
  • Causa
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Acción
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
Retiro De Equipo (Recall) de Kendall
  • Tipo de evento
    Recall
  • ID del evento
    30196
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0097-05
  • Fecha de inicio del evento
    2004-10-08
  • Fecha de publicación del evento
    2004-11-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35386
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Needle, Hypodermic, Single Lumen - Product Code FMI
  • Causa
    Needle cannula may separate from the hub during use.
  • Acción
    Recall letters requesting product return were mailed to all customers on October 8, 2004
Retiro De Equipo (Recall) de Device Recall VZV IgG ELISA 96 Well Kit
  • Tipo de evento
    Recall
  • ID del evento
    50691
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1003-2010
  • Fecha de inicio del evento
    2008-08-27
  • Fecha de publicación del evento
    2010-03-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76383
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster - Product Code LFY
  • Causa
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Acción
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
Retiro De Equipo (Recall) de Device Recall VZV IgM ELISA 96 Well Kit
  • Tipo de evento
    Recall
  • ID del evento
    50691
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1004-2010
  • Fecha de inicio del evento
    2008-08-27
  • Fecha de publicación del evento
    2010-03-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76384
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Antiserum, Cf, Varicella-Zoster - Product Code GQX
  • Causa
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Acción
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
Retiro De Equipo (Recall) de Device Recall LIAISON Analyzer
  • Tipo de evento
    Recall
  • ID del evento
    50704
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1042-2009
  • Fecha de inicio del evento
    2008-12-05
  • Fecha de publicación del evento
    2009-03-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76461
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Colorimeter, Photometer, Spectrophotometer for clinical use - Product Code JJQ
  • Causa
    Diasorin determined that there was a potential for a short to occur in a a residual starter pump electrical cable in the liaison (r) analyzer.
  • Acción
    DiaSorin Inc authorized Field Service Engineer has visited the sites and performed the necessary field correction. Upon completion of their work, the field service engineer generated a Field Service Report and a copy was left with the customer.
Retiro De Equipo (Recall) de Device Recall Stryker PainPump2 BlockAid
  • Tipo de evento
    Recall
  • ID del evento
    50189
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0926-2009
  • Fecha de inicio del evento
    2008-11-12
  • Fecha de publicación del evento
    2009-01-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-11-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76476
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Pump, infusion - Product Code FRN
  • Causa
    The pump may display an e-4 error message, which causes the pump to stop dispensing the pain medication.
  • Acción
    Consignees were notified via letter dated 11/12/08 and instructed to locate and destroy the affected lots. Customers were also instructed to complete and return the enclosed Business Reply form via fax (336-499-8603) to Stryker Instruments Regulatory Department. For questions regarding the recalled product, please contact Stryker Instruments at 1-800-800-4236, extension 3808 or extension 4056.
Retiro De Equipo (Recall) de Device Recall ReSolve Halo Open Back Halo Ring
  • Tipo de evento
    Recall
  • ID del evento
    50706
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1507-2009
  • Fecha de inicio del evento
    2008-11-09
  • Fecha de publicación del evento
    2009-06-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-04-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76483
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Skull Tong for Traction - Product Code HAX
  • Causa
    Ossur initiated the recall after their investigation of some complaints found that in some instances the ceramic pins are difficult to screw through the halo ring.
  • Acción
    Ossur contacted direct consignees and sub-accounts beginning on November 10 , 2008 via a phone call informing them of the recall, and the reason as stated in the public reason for recall. Consignees were asked to check their inventory for any of the identified products and contact them with this information. The firm developed a telephone script for the customer service representatives to use. Ossur then forwarded a notification letter to the affected customers beginning on November 12, 2008 via US Postal Service. In the event that any of these parts have already been applied to a patient, Ossur advised customers to follow their normal follow-up protocols, ensuring that the ceramic pins are properly fixed in the skull. At the time of the phone calls Ossur did not have sterilized open back replacement rings available; however, they offered their ReSolve Closed Back Halo ring as an alternative. The firm estimated that the normal product offering should be available once again in approximately four to six weeks from the date of the phone call.
  • 1
  • 2
  • 3
  • …
  • Next ›
  • Last »

Acerca de la base de datos

Explore más de 120,000 registros de retiros, alertas y notificaciones de seguridad de dispositivos médicos y sus conexiones con los fabricantes.

  • Preguntas frecuentes
  • Acerca de la base de datos
  • Contáctenos
  • Créditos

Historias en su correo

¿Trabaja en la industria médica? ¿O tiene experiencia con algún dispositivo médico? Nuestra reportería no ha terminado. Queremos oír de usted.

¡Cuéntanos tu historia!

Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

Descargar la data

La International Medical Devices Database está bajo la licencia Open Database License y sus contenidos bajo la licencia Creative Commons Attribution-ShareAlike . Al usar esta data, siempre citar al International Consortium of Investigative Journalists. Puede descargar acá una copia de la base de datos.

Descargar todo (zipped)