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  • Dispositivo 2589
  • Fabricante 31827
  • Evento 2705
  • Implante 0
Retiro De Equipo (Recall) de ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    79827
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2000-10-18
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Fasttake meters may display what appears as the letter 'y' in the middle digit when the meter is set in mmol/l. this was a software problem.
Retiro De Equipo (Recall) de Device Recall AEROSET
  • Tipo de evento
    Recall
  • ID del evento
    26640
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1142-03
  • Fecha de inicio del evento
    2000-12-29
  • Fecha de publicación del evento
    2003-08-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-08-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28044
  • 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
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
  • Causa
    Ict assays run using a manual dilution will not be calculated correctly by the software.
  • Acción
    Product Information letter dated 29 December 2000 was sent to all AEROSET customers.
Retiro De Equipo (Recall) de Device Recall SoftPath
  • Tipo de evento
    Recall
  • ID del evento
    35375
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1252-06
  • Fecha de inicio del evento
    2001-01-09
  • Fecha de publicación del evento
    2006-07-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-07-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45949
  • 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
    pathology lab software - Product Code JQP
  • Causa
    The client had made a decision to use the softpath module in a nonstandard manner. under specific circumstances, incorrect text may appear on a patient report.
  • Acción
    The firm issued a software correction letter to its consignees 1/9/2001, advising them of the problem and supplied them with a software patch ICC number 3618 also referred to as release 3.0. The firm advised its clients that the installation of this software to their system was mandatory.
Retiro De Equipo (Recall) de Device Recall AEROSET
  • Tipo de evento
    Recall
  • ID del evento
    25770
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0843-03
  • Fecha de inicio del evento
    2001-10-02
  • Fecha de publicación del evento
    2003-05-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-04-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26456
  • 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
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
  • Causa
    Extensive use of cuvettes causes inaccurate results. preventative maintenance did not specify replacement schedule.
  • Acción
    The firm issued a letter to affected consignees on or about 10/02/2001 notifying the consignees that an Abbott Field Representative will perform a one-time cuvette upgrade to the consignee''s AEROSET system.
Retiro De Equipo (Recall) de Device Recall Architect
  • Tipo de evento
    Recall
  • ID del evento
    26639
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1133-03
  • Fecha de inicio del evento
    2001-12-10
  • Fecha de publicación del evento
    2003-08-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-08-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28043
  • 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
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
  • Causa
    Under specific conditions, the system can allow an incorrect sample id to be assigned to another sample in a different carrier.
  • Acción
    Technical Service Bulletin 114-041 was sent to the Abbott Laboratories Field Service Organization with instructions to correct all ARCHITECT i 2000 systems worldwide.
Retiro De Equipo (Recall) de Device Recall ARCHITECT
  • Tipo de evento
    Recall
  • ID del evento
    30764
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0435-05
  • Fecha de inicio del evento
    2001-12-14
  • Fecha de publicación del evento
    2005-01-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-11-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36550
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
    unknown device name - Product Code LID
  • Causa
    Falsely elevated b-hcg results can occur when running b12 and b-hcg assays on the same analyzer due to carryover. b-12 results are not impacted.
  • Acción
    The firm initiated the recall via letter on December 14 and 16, 2004 directing consignees to perform the two tests on different machines or to contact the customer service representative in the event the consignee only has one machine.
Retiro De Equipo (Recall) de VITROS ECI IMMUNODIAGNOSTIC ANALYZER - CLASS II
  • Tipo de evento
    Recall
  • ID del evento
    17743
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2002-01-24
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Low and false positive results from assay.
Retiro De Equipo (Recall) de Device Recall ARCHITECT
  • Tipo de evento
    Recall
  • ID del evento
    27180
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0172-04
  • Fecha de inicio del evento
    2002-05-08
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-11-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29383
  • 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
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
  • Causa
    If the interlock cable connected to the door lid sensor is disconnected or fails, the lid is detected as closed even though it may be open.
  • Acción
    Firm sent technical service bulletins with corrective instructions to consignees with all existing ARCHITECT i 2000 processing modules in February 2003.
Retiro De Equipo (Recall) de Device Recall Cerebrospinal Fluid Test Kit
  • Tipo de evento
    Recall
  • ID del evento
    26227
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0973-03
  • Fecha de inicio del evento
    2002-05-16
  • Fecha de publicación del evento
    2003-07-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27313
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
  • Causa
    The csf gels were manufactured incorrectly resulting in irregular wavy bands.
  • Acción
    The firm contacted the consignee by telephone on 5/16/2002.
Retiro De Equipo (Recall) de Device Recall AxSYM
  • Tipo de evento
    Recall
  • ID del evento
    27179
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0173-04
  • Fecha de inicio del evento
    2002-06-06
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-08-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29382
  • 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
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
  • Causa
    Clamp can cause misaligned seating of heater block resulting in inaccurate dispension of meia wash buffer or mup into the reaction cell. causes inconsistent results.
  • Acción
    All consignees received Technical Service Bulletin (TSB) #83-081. This TSB gave instructions on how to install the AxSYM Small Heater Block clamp upgrade implemented June 6, 2002.
Retiro De Equipo (Recall) de AEROSET
  • Tipo de evento
    Recall
  • ID del evento
    25771
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0844-03
  • Fecha de inicio del evento
    2002-08-15
  • Fecha de publicación del evento
    2003-05-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-04-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26457
  • 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
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
  • Causa
    Design of high concentration waste line causes formation of a precipitate in the waste line causing overflow of waste.
  • Acción
    The firm sent Technical Service Bulletins dated August 15, 2002 to consignees. Field Representatives are correcting the device in the field. A customer letter was released on August 20, 2002 to provide customers actions to take to prevent the occurrance.
Retiro De Equipo (Recall) de Genuine One Touch Test Strips
  • Tipo de evento
    Recall
  • ID del evento
    25193
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0399-03
  • Fecha de inicio del evento
    2002-10-08
  • Fecha de publicación del evento
    2002-12-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-09-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25359
  • 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
    Products labeled 'for sale outside the usa and canada,' were being offered for sale in the u.S.
  • Acción
    Letters were sent via regular mail to customers on/about 10/08/02 with a response card attached. Customers were informed of the recall, and were urged to contact their accounts and to return their outstanding recall stock to River City Drug for full credit.
Retiro De Equipo (Recall) de SureStep 50 Test Strips
  • Tipo de evento
    Recall
  • ID del evento
    25193
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0398-03
  • Fecha de inicio del evento
    2002-10-08
  • Fecha de publicación del evento
    2002-12-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-09-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25358
  • 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
    Products labeled 'for sale outside the usa and canada,' were being offered for sale in the u.S.
  • Acción
    Letters were sent via regular mail to customers on/about 10/08/02 with a response card attached. Customers were informed of the recall, and were urged to contact their accounts and to return their outstanding recall stock to River City Drug for full credit.
Retiro De Equipo (Recall) de Microtainer
  • Tipo de evento
    Recall
  • ID del evento
    25170
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0447-03
  • Fecha de inicio del evento
    2002-10-16
  • Fecha de publicación del evento
    2003-01-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-04-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25331
  • 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
    Tubes, Vials, Systems, Serum Separators, Blood Collection - Product Code JKA
  • Causa
    Insufficient amount of edta found within the tube causing clotting and erroneous platelet counts.
  • Acción
    Becton Dickinson contacted their Distributors and customers with return instructions via certified mail on or about Oct. 16, 2002.
Retiro De Equipo (Recall) de Misys Laboratory
  • Tipo de evento
    Recall
  • ID del evento
    25010
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0324-03
  • Fecha de inicio del evento
    2002-10-18
  • Fecha de publicación del evento
    2002-12-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-12-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25011
  • 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
    Calculator/Data Processing Module, For Clinical Use - Product Code JQP
  • Causa
    Software anomally - animal ranges, when desired on reports, are defaulting to human male ranges.
  • Acción
    Notice of recall was sent by fax on October 18, 2002. A software fix will be available for version 5.3 in January 2003. Users will be notified again of this new release and be urged to update from version 5.23 to version 5.3. Completion of the recall is estimated to be in March 2003.
Retiro De Equipo (Recall) de Misys Laboratory
  • Tipo de evento
    Recall
  • ID del evento
    25009
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0647-03
  • Fecha de inicio del evento
    2002-10-18
  • Fecha de publicación del evento
    2003-03-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-12-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25010
  • 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
    Calculator/Data Processing Module, For Clinical Use - Product Code JQP
  • Causa
    Software anomaly, incorrect coding. some comments were not transfered when coming from the reference laboratory interface.
  • Acción
    A product workaround was communicated to the two affected sites by facsimile on October 18, 2002. The recall is complete.
Retiro De Equipo (Recall) de Misys Laboratory versions 5.2, 5.23, or 5.3 with ADT Interface to Co...
  • Tipo de evento
    Recall
  • ID del evento
    25077
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0325-03
  • Fecha de inicio del evento
    2002-10-24
  • Fecha de publicación del evento
    2002-12-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25115
  • 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
    Calculator/Data Processing Module, For Clinical Use - Product Code JQP
  • Causa
    Interfacing software systems have inconsistent character recognition characteristics.
  • Acción
    A recall notice was sent to hospitals on October 24, 2002. It communicated a temporary procedure to work around the problem. Also mentioned was the availabllity of a utility to detect and report suspected duplicate Medical Record Numbers.
Retiro De Equipo (Recall) de Misys Laboratory version 5.2 with Results Interface 14
  • Tipo de evento
    Recall
  • ID del evento
    25074
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0319-03
  • Fecha de inicio del evento
    2002-10-28
  • Fecha de publicación del evento
    2002-12-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-12-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25112
  • 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
    Calculator/Data Processing Module, For Clinical Use - Product Code JQP
  • Causa
    Software coding error caused data formatting error.
  • Acción
    The coding error was detected in one of two sister hospitals using like systems. The defect was corrected August 16, 2002.
Retiro De Equipo (Recall) de Device Recall Cholesterol Reagent
  • Tipo de evento
    Recall
  • ID del evento
    25081
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0404-03
  • Fecha de inicio del evento
    2002-11-07
  • Fecha de publicación del evento
    2002-12-31
  • 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=25124
  • 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
    Enzymatic Esterase--Oxidase, Cholesterol - Product Code CHH
  • Causa
    Potential for reporting lower than actual hdl (cholesterol) results due to low qc recovery.
  • Acción
    The firm notified Distributors by telephone on 11/4/02 and end-users by Certified Mail on 11/4/02. Distributors and End-users are requested to dispose of product and return label for replacement product.
Retiro De Equipo (Recall) de Device Recall Precision Blood Glucose Test Strips
  • Tipo de evento
    Recall
  • ID del evento
    25087
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0403-03
  • Fecha de inicio del evento
    2002-11-08
  • Fecha de publicación del evento
    2002-12-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25134
  • 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
    Glucose Oxidase, Glucose - Product Code CGA
  • Causa
    Use of glucose blood strips may provide false high results.
  • Acción
    Abbott notified the two hospitals by telephone on 11/8/02. Both responded and returned product.
Retiro De Equipo (Recall) de Misys Laboratory version 5.3
  • Tipo de evento
    Recall
  • ID del evento
    25162
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0422-03
  • Fecha de inicio del evento
    2002-11-15
  • Fecha de publicación del evento
    2003-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-06-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25318
  • 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
    Calculator/Data Processing Module, For Clinical Use - Product Code JQP
  • Causa
    Software development logic defect.
  • Acción
    Notice of the recall was sent to customers by fax on 11/15/2002.
Retiro De Equipo (Recall) de Access Progesterone Assay, Part number 33550.
  • Tipo de evento
    Recall
  • ID del evento
    25392
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0494-03
  • Fecha de inicio del evento
    2002-12-06
  • Fecha de publicación del evento
    2003-01-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-07-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25729
  • 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
    Radioimmunoassay, Progesterone - Product Code JLS
  • Causa
    Primary tube sampling issue may cause false low results.
  • Acción
    Recall letters were sent to customers on 12/6/2002 informing them to not process the sample directly from the primary collection tubes but to pour off a bit into a separate tube. Labs are to incorporate this into their Standard Operating Procedures until the firm can identify another resolution to the problem.
Retiro De Equipo (Recall) de Device Recall Misys Laboratory
  • Tipo de evento
    Recall
  • ID del evento
    25238
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0497-03
  • Fecha de inicio del evento
    2002-12-06
  • Fecha de publicación del evento
    2003-01-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25439
  • 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
    Calculator/Data Processing Module, For Clinical Use - Product Code JQP
  • Causa
    Software system defect resulting in incomplete patient results information.
  • Acción
    Product Safety Notice, PSN-02-L31 will be faxed to all affected customers. The notice provides product users with a description of the problem, an effective workaround, and the estimated release of coding modifications to the software version impacted.
Retiro De Equipo (Recall) de Device Recall TDx/TDxFLx
  • Tipo de evento
    Recall
  • ID del evento
    25220
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0691-03
  • Fecha de inicio del evento
    2002-12-11
  • Fecha de publicación del evento
    2003-03-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-06-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25409
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
    unknown device name - Product Code 91
  • Causa
    Unexpected false positive tca results.
  • Acción
    A Device Correction letter was mail to all customers on 12 /11/02. The letter explained the reason for the recall and provided specific instructions.
Retiro De Equipo (Recall) de Device Recall ADx
  • Tipo de evento
    Recall
  • ID del evento
    25220
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0690-03
  • Fecha de inicio del evento
    2002-12-11
  • Fecha de publicación del evento
    2003-03-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-06-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25408
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
    unknown device name - Product Code 91
  • Causa
    Unexpected false positive tca results.
  • Acción
    A Device Correction letter was mail to all customers on 12 /11/02. The letter explained the reason for the recall and provided specific instructions.
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