• 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 1149
  • Fabricante 31827
  • Evento 1201
  • Implante 0
Retiro De Equipo (Recall) de VIDAS CHLAMYDIA
  • Tipo de evento
    Recall
  • Fecha
    2003-08-06
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-2-lots-du-dm-div-vidas-chlamydia-de-par-biomerieux
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    The company BIOMERIEUX withdraws from the market batches 0402120 and 0402180 (February 2004) of the in vitro diagnostic medical device called VIDAS CHLAMYDIA - reference 30101, following a stability problem, which, after July 24, 2003, may have resulted in False negative results .. In agreement with the Afssaps, the company Biomérieux requires that all patients whose results were made negative after July 24, 2003, be retested with another batch of this device .. This device allows the detection of the Chlamydia antigen from endocervical and urethral samples, using the Enzym Linked Fluorescent Assay (ELFA) technique on the Vidas automaton.
Alerta De Seguridad para DIAGNOSTIC REAGENTS FOR USE IN VITRO VIDAS CHLAMYDIA / REF. 30101 ANVISA...
  • Tipo de evento
    Safety alert
  • ID del evento
    732
  • Fecha
    2003-08-26
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    The company informs that a credit will be generated to the Laboratories, and that it has already begun the import process in emergency catater, once all the stock has been totally compromised due to the collection. If you received a letter dated August 26, 2003, complete the Return Certificate and return it by fax 21-2445.9523. For further information, please contact BIOMÉRIEUX BRASIL SA, by calling 0800 26 4848 - option 2, or your local representative.
  • Causa
    The process of decreasing the stability of a raw material that composes the reagents was detected, this fact could generate false negative results.
  • Acción
    Issue of letter dated August 26, 2003 - Notice of Collection - requesting to suspend the use of lots and to retest all samples of negative results since July 24.
Notificaciones De Seguridad De Campo acerca de Probe Tec Urine Processing Kit
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    00309/05
  • Fecha
    2005-02-16
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/08/2005/00309-05_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Tosoh for AIA-600 II
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    02835/04
  • Fecha
    2005-03-14
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/08/2004/02835-04_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
  • Notas adicionales en la data
Retiro De Equipo (Recall) de ACCUPROBE Group B Streptococcus / Mycobacterium Culture Confirmation...
  • Tipo de evento
    Recall
  • ID del evento
    2009-0022
  • Fecha
    2009-01-14
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notas adicionales en la data
    Source: M2
  • Causa
    Device failure / feature before use - material / component.
Notificaciones De Seguridad De Campo acerca de ACCUPROBE Group B Streptococcus kit, ACCUPROBE Myc...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    00074/09
  • Fecha
    2009-01-27
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/08/2009/00074-09_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
  • Notas adicionales en la data
Retiro De Equipo (Recall) de Gen-Probe AccuProbe Group B Streptococcus Culture Identification Tes...
  • Tipo de evento
    Recall
  • ID del evento
    2011-0200
  • Fecha
    2011-03-29
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notas adicionales en la data
    Source: NCAR
  • Causa
    Device failure / feature before use - manufacturing.
Alerta De Seguridad para microscan synergies plus and microscan rapid/s plus negative panels
  • Tipo de evento
    Safety alert
  • Fecha
    2013-09-05
  • Fecha de publicación del evento
    2013-09-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130905.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: siemens microscan synergies plus and microscan rapid/s plus negative panels the united states food and drug administration (fda) has issued a medical device safety alert concerning microscan synergies plus and microscan rapid/s plus negative panels, manufactured by siemens healthcare diagnostics, inc. the affected products are identified as follows:- synergies plus negative urine combo 1- 10444745 / b1025-106 synergies plus negative combo 2 - 10444747 / b1025-108 synergies plus negative breakpoint combo 7 - 10444748 / b1025-109 synergies plus negative urine combo 2 - 10444749 / b1025-112 synergies plus negative urine combo 5 - 10483101 / b1025-115 microscan synergies plus and microscan rapid/s plus negative panels are reporting false susceptible and false intermediate results for imipenem and meropenem antimicrobial susceptibility testing when using the microscan walkaway system. this defect may lead to treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy. this recall covers 78,020 panels distributed in the us between 07/11/2011 and 08/02/2013. according to the fda, the manufacturer has sent an urgent field safety notice dated 21 august 2013, to all affected customers. the letter identified the defective products, problem and actions to be taken and also instructed customers to suppress all reporting of sensitive and intermediate results for imipenem and meropenem. in addition, siemens recommends that customers consider the need to review previous test results, conduct patient follow-up, and/or repeat testing. for details, please visit the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm367217.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm367163.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 september 2013.
Notificaciones De Seguridad De Campo acerca de Microscan® Microbiology Systems regarding Microsca...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    05265/13
  • Fecha
    2013-09-09
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/08/2013/05265-13_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de microscan microbiology systems
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2611
  • Fecha
    2013-09-10
  • País del evento
    Italy
  • Fuente del evento
    MSHM
  • URL de la fuente del evento
    http://www.salute.gov.it/portale/news/p3_2_1_3_1_1.jsp?lingua=italiano&menu=notizie&p=avvisi&tipo=dispo&id=2611
  • Notas / Alertas
    Italian data is current through August 2018. All of the data comes from Ministero della Salute (Health Ministry), 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 data from the U.S. and Italy.
  • Notas adicionales en la data
  • Acción
    Safety instructions
Notificaciones De Seguridad De Campo acerca de determination of bacterial susceptibility to imipe...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2529
  • Fecha
    2013-09-11
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-siemens-healthcare-diagnostics-dotycz%C4%85ca-oznacze%C5%84-wra%C5%BCliwo%C5%9Bci-bakterii
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Siemens Healthcare Diagnostics safety note on the determination of the sensitivity of bacteria to imipenem and / or meropenem using MicroScan Synergies plus and raplD / S plus panels on the WalkAway analyzer
Alerta De Seguridad para microscan synergies plus and microscan rapid/s panels
  • Tipo de evento
    Safety alert
  • Fecha
    2013-09-23
  • Fecha de publicación del evento
    2013-09-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130923a.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: siemens microscan synergies plus and microscan rapid/s panels the united states food and drug administration (fda) has issued a field safety notice concerning microscan synergies plus and microscan rapid/s panels, manufactured by siemens healthcare diagnostics, inc. the affected products are identified as follows:- synergies plus negative urine combo 1- 10444745 / b1025-106 synergies plus negative combo 2 - 10444747 / b1025-108 synergies plus negative breakpoint combo 7 - 10444748 / b1025-109 synergies plus negative urine combo 2 - 10444749 / b1025-112 synergies plus negative urine combo 5 - 10483101 / b1025-115 microscan plus negative combo 3 (sold outside of us only) – 10444600 / b1016-201 microscan plus negative urine combo 4 (sold outside of us only) - 10444601 / b1016-202 microscan plus negative breakpoint combo 4 (sold outside of us only) – 10460272 / b1016-203 microscan rapid/s panels nc3.11 (sold in japan only) - 10444792 / j1025-311 microscan rapid/s panels nc3.12 (sold in japan only) – 10444793 / j1025-312 microscan rapid/s panels nc3.33 (sold in japan only) – 10444794 / j1025-333 this field safety notice has update of affected products, concerning a medical device safety alert previously issued (with links: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm367217.Htm; and http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm368112.Htm). according to this field safety notice, there is confirmed increase in false susceptible and false intermediate misreads for imipenem and/or meropenum on synergies plus negative and rap id/s plus negative panels read on walk away system. for details, please visit the following fda websites: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm?action=detail&id=66058&w=09182013&lang=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 september 2013.
Alerta De Seguridad para Etest PIP/TAZO/CON‐4 PTC 256
  • Tipo de evento
    Safety alert
  • Fecha
    2015-11-27
  • Fecha de publicación del evento
    2015-11-27
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151127a.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: biomérieux etest pip/tazo/con‐4 ptc 256 medical device manufacturer, biomérieux, has issued a medical device safety alert concerning its etest pip/tazo/con‐4 ptc 256. [product reference numbers: 412434, 412433, 521418 and 521458] based on a low minimum inhibitory concentration (mic) report from the field, the manufacturer initiated a complaint investigation (pr 929981) to confirm product performance and determine root cause. as a result of the investigation, the following was identified: isolates (enterbacteria strains) were tested with agar dilution and broth micro dilution reference method: using eucast breakpoints (mic< or =8: susceptible; mic>16: resistant), etest pip/tazo showed a higher frequency of erroneous results, false susceptible results, when comparing to the referenced method (broth-micro dilution). performance using clsi breakpoints (compared to broth micro dilution referenced method) was similar to eucast. in conclusion, the data analysis demonstrates that the etest piperacillin/tazobactam performance has shifted when compared to the published performance characteristics. according to the manufacturer, the risk to patients as a result of the etest pip/tazo/con‐4 ptc 256 performance shift is the potential for reporting erroneous results for piperacillin/tazobactam; specifically false susceptible results. this risk may lead to medical intervention for the patient because the erroneous result could negatively influence the selection of antibiotic therapy. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 november 2015.
Notificaciones De Seguridad De Campo acerca de etest piperacillin / tazobactam
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6218
  • Fecha
    2015-11-28
  • País del evento
    Italy
  • Fuente del evento
    MSHM
  • URL de la fuente del evento
    http://www.salute.gov.it/portale/news/p3_2_1_3_1_1.jsp?lingua=italiano&menu=notizie&p=avvisi&tipo=dispo&id=6218
  • Notas / Alertas
    Italian data is current through August 2018. All of the data comes from Ministero della Salute (Health Ministry), 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 data from the U.S. and Italy.
  • Notas adicionales en la data
  • Acción
    recall
Retiro De Equipo (Recall) de Etest Pip / tazo 4 PTC 256
  • Tipo de evento
    Recall
  • ID del evento
    15DIV1332
  • Fecha
    2015-12-09
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/bandelettes-etest-pip-tazo-4-ptc-256-biomerieux-rappel-de-lots
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    The ANSM has been informed of the implementation of a withdrawal of batches made by the company Biomérieux .. The users concerned have received the attached mail (09/12/2015) (180 KB). This security action is registered at ANSM under the number 15DIV1332
Retiro De Equipo O Alerta De Seguridad para Etest PIP / CUP / CON-4 PTC 256
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2015-12-10
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Cessation of the use of certain references and batches of the antimicrobial susceptibility test Etest PIP / TAZO / CON-4 PTC 256, manufactured by BioMérieux SA, France, due to the possibility of obtaining erroneous results (false susceptible).
Alerta De Seguridad para antimicrobial susceptibility test etest piperacilline / tazobactam 4 PTC...
  • Tipo de evento
    Safety alert
  • ID del evento
    RRD-031215
  • Número del evento
    INVIMA 2009RD-0001247
  • Fecha
    2015-12-11
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=164
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    False sensitive results after submitting enterobacteria strains to tests with gel dedilution reference methods and microdilution in liquid medium, using the eucast critical concentrations (cmi <0u = 8: sensitive, cmi> 16: resistant). the risk to the patient is obtaining the potentially wrong result, in particular the result is falsely sensitive, directly influencing the medical decision in the selection of antibiotic therapy.
Notificaciones De Seguridad De Campo acerca de Etest® Piperacillin / Tazobactam
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2015(31)
  • Fecha
    2015-12-15
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/SN2015-31&id=7d250426-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Notas adicionales en la data
Retiro De Equipo (Recall) de Etest® Piperacillin/Tazobactam (4 μg/mL) PTc 0.016-256
  • Tipo de evento
    Recall
  • ID del evento
    2016-0045
  • Fecha
    2016-01-11
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notas adicionales en la data
    Source: FSCA
  • Causa
    Device failure / feature before use - manufacturing.
Notificaciones De Seguridad De Campo acerca de Etest PIP/TAZO/CON‐4 PTC 256
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    08929/15
  • Fecha
    2016-01-28
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/08/2015/08929-15_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Etest® Piperacillin/Tazobactam (4 μg/mL) PTc 0.016...
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2016020314
  • Fecha
    2016-02-02
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2016/02/etest-piperacillintazobactam-4-gml-ptc-0016-256/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Etest PIP/TAZO/CON-4 PTC 0.016-256 µg/ml
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2016/130 & FSCA 2709
  • Fecha
    2016-02-09
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20170817160421/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2016-130-131.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Etest PTc PIPERACILLIN/TAZOBACTAM (4mg/ml)
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2016/131 & FSCA 2709
  • Fecha
    2016-02-09
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20170817160421/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2016-130-131.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Alerta De Seguridad para Vitek 2 Gram Positive Susceptibility Test Cards
  • Tipo de evento
    Safety alert
  • Fecha
    2016-05-18
  • Fecha de publicación del evento
    2016-05-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160518b.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: biomerieux vitek 2 gram positive susceptibility test cards the united states food and drug administration (fda) has issued a medical device safety alert concerning vitek 2 gram positive susceptibility test cards, manufactured by biomerieux. the affected devices are identified as follows:- (ast-p636 ref 417951), (ast-p639 ref 418662), (ast-p640 ref 418579), (ast-p641 ref 418590), (ast-p642 ref 418604), (ast-p643 ref 418671), (ast-p644 ref 418673), (ast-p645 ref 419602), (ast-p646 ref 420144) according to the fda, the product inserts fail to identify performance limitation related to eucast breakpoints for teicolplanin. for details, please refer to the fda website: http://www.Accessdata.Fda.Gov/scripts/ires/index.Cfm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 may 2016.
Retiro De Equipo (Recall) de ETest® PIP/TAZO/CON-4 PTC 256
  • Tipo de evento
    Recall
  • Fecha
    2016-06-27
  • País del evento
    Lebanon
  • Fuente del evento
    RLMPH
  • URL de la fuente del evento
    https://www.moph.gov.lb/userfiles/files/Medical%20Devices/27-6-2016/EtestPIP-TAZO-CON-4PTC256.pdf
  • Notas / Alertas
    Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
  • Notas adicionales en la data
  • 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.