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  • Dispositivo 1149
  • Fabricante 31827
  • Evento 1201
  • Implante 0
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 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 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 Simplexa HSV 1 & 2 Direct / Flu A/B & RSV Direct /...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    07226/16
  • Fecha
    2017-02-01
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/08/2017/07226-16_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 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
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
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
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 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.
Alerta De Seguridad para VITEK 2 Gram Positive Antimicrobial Susceptibility Testing (AST) Cards
  • Tipo de evento
    Safety alert
  • Fecha
    2018-08-24
  • Fecha de publicación del evento
    2018-08-24
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180824a.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 antimicrobial susceptibility testing (ast) cards the united states food and drug administration (fda) has issued a medical device safety alert concerning vitek 2 gram positive cefoxitin screen and vitek 2 gram positive ast for oxacillin [lot numbers: all lots of gram positive ast cards with oxacillin and cefoxitin tests; manufacturing and distribution dates: 8 february 2017 to present], manufactured by biomerieux. the manufacturer is recalling the affected products because of false negative or false susceptible results for some strains of methicillin-resistant staphylococcus aureus (mrsa). it is continuing to investigate the issue to determine the root cause of the failure and the prevalence of the strains that are subject to erroneous results. according to the manufacturer, missed diagnosis and inappropriate treatment of mrsa could cause severe health consequences, including lack of treatment for a mrsa infection, and death. the manufacturer recommends that labs confirm potential mrsa upon activation of the software bioart rule. the mrsa safety alert letter is issued directing labs to: implement a custom vitek 2 system software bioart rule to aid in mitigating potential non-detection of mrsa when testing oxacillin (ox) and cefoxitin screen (oxsf) on vitek 2, enable the advanced expert system on the vitek 2 systems software to ensure that the appropriate forcing rules are applied to test results regardless of the parameter set in use, and use the existing strain submission system to send isolates of suspect strains of mrsa to the manufacturer for additional testing. for details, please refer to the following fda website: https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm618135.Htm if you are in possession of the products, please contact your supplier for necessary actions. posted on 24 august 2018.
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.
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.
Retiro De Equipo (Recall) de Etest PIPTAZO PTC 256 (used for testing of Enterobacteria strains). ...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-01171-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-12-02
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01171-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    It has been identified that isolates (enterobacteria 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).The risk to patients as a result of the 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.
  • Acción
    Biomerieux is advising users to discontinue use and discard any remaining units. Biomerieux is advising users to discuss any concerns regarding previously reported results with the Laboratory Medical Director. This action has been closed-out on 31/08/2016.
Retiro De Equipo (Recall) de VITEK2 AST-YS06 & VITEK2 AST-YS07 Test Kits
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00378-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-05-01
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00378-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    An issue related to out-of-range-low (oorl) flucytosine (fct) qc results for candida krusei atcc 6258, the package insert qc strain, has been identified in association with the vitek 2 ast-ys06 and ast-ys07 test kits.Internal investigation at the manufacturing site has observed the oorl fct qc results for candida krusei atcc 6258. internal testing of fct with additional isolates shows a trend to call one to two doubling dilutions low. candida krusei are intrinsically resistant to fct and are therefore forced "resistant" in vitek 2 software (as of version 7.01); the vitek® 2 7.01 fct forcing rule does not apply to other candida species. user reports have been limited to the atcc 6258 qc strain; however, impact to patient results for candida krusei and other yeast cannot be ruled out.
  • Acción
    For the referenced test kits (VITEK 2 AST-YS06 or AST-YS07), laboratories are advised to not report Flucytosine (FCT) results for any organism until the new formulation (fct02n) is released. This issue will be resolved with the release of a new Flucytosine (fct02n) formulation. The estimated timeframe for introduction of cards with the new Flucytosine formulation is six months. This action has been closed out on 09/08/2016.
Retiro De Equipo (Recall) de VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Pac...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00820-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-07-24
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00820-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Ortho-clinical diagnostics (ocd) received complaints of results for patient and proficiency samples were elevated in some instances. proficiency sample results when using vitros ca 19-9 kit lot 1320, compared to previous kit lots used and analysed (ocd internal testing), found an overall average positive bias of approximately +30% for samples within the normal range (<=37 u/ml) and +17% for samples above the normal range (>37 u/ml).
  • Acción
    Laboratories are being advised to immediately discontinue using and discard all remaining inventory of VITROS CA19-9 Calibrators and Reagent Packs, Lot 1320. Review previously reported results using VITROS CA 19-9 Reagent Packs, Lot 1320 and discuss any concerns regarding previously reported results with your Laboratory Medical Director or the requesting physician to determine the appropriate course of action. Ortho-Clinical Diagnostics (OCD) will provide credits/replace stock of any product affected by this recall. This action has been closed-out on 12/08/2016.
Retiro De Equipo (Recall) de VITEK 2 60/XL and VITEK 2 Compact systems (In vitro diagnostic medic...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2013-RN-00168-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-02-22
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00168-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Under specific conditions, vitek 2 60/xl and vitek 2 compact pc systems connected to a laboratory information system have the potential to link a test result to an incorrect patient record. the four conditions required to potentially cause an occurrence of this issue are:- patient demographics option is enabled- patient demographics are not associated with the isolate- user does not resolve qualified isolates- laboratory re-uses lab ids (accession numbers) prior to qualified isolates being resolved.
  • Acción
    Biomerieux is updating the instructions for use (IFU), addendum to the software user manual, to include appropriate instructions for resolution of Qualified isolates as a short term action. Biomerieux is implementing a software solution to reduce the likelihood of occurrence of this issue in the next software update, version 7.01 targeted for launch in November 2013.
Retiro De Equipo (Recall) de Reagent kits for identifying and determining the sensitivity of micr...
  • Tipo de evento
    Recall
  • ID del evento
    02И-1334/16, ФСЗ 2010/08614
  • Fecha
    2016-07-01
  • Fecha de publicación del evento
    2016-07-04
  • País del evento
    Russian Federation
  • Fuente del evento
    FSSH
  • URL de la fuente del evento
    http://www.roszdravnadzor.ru/services/unreg
  • Notas / Alertas
    Russian data is current through January 2019. All of the data comes from the Federal Service for Surveillance in Healthcare, 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 Russia.
  • Notas adicionales en la data
    Manufacturer Recall
Retiro De Equipo (Recall) de ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFOTAXIME
  • Tipo de evento
    Recall
  • ID del evento
    132729
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2015-06-11
  • 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
    An internal investigation identified a performance deviation associated with quality control testing of retained product samples indeed the qc results were out of range resulting in false resistant strains.
Retiro De Equipo (Recall) de HERPESELECT 1 AND 2 DIFFERENTIATION IMMUNOBLOT IGG
  • Tipo de evento
    Recall
  • ID del evento
    90923
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2007-07-06
  • 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
    2 complaints received involving immunoblot strip lots indicating that in a small % of samples hsv common antigen band appears lighter (less reactive) than leading control band. may lead to false negative.
Retiro De Equipo (Recall) de VIDAS CHLAMYDIA
  • Tipo de evento
    Recall
  • ID del evento
    60660
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2003-09-10
  • 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
    Lots # 402120 & 402180 are experiencing stability issues due to raw material: could lead to report a false negative result.
Retiro De Equipo (Recall) de SIMPLEXA FLU A/B & RSV DIRECT
  • Tipo de evento
    Recall
  • ID del evento
    27527
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2014-01-20
  • 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
    Focus diagnostics has received some customer complaints of simplexa flu a/b & rsv lots with sporadic false positive rsv signals which may result in a higher rsv false positive rate. the potential false positive rsv results are unpredictable within the identified lots and may not be easily identified during testing. this issue is only seen with the rsv (m gene) fluorescent probe-primer. the influenza a/b results are not impacted since the fluorescent probe-primers to detect influenza a/b viruses are different than those detecting rsv.
Retiro De Equipo (Recall) de WELCH ALLYN PIC 50
  • Tipo de evento
    Recall
  • ID del evento
    24614
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2006-08-04
  • 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
    An electrical contact problem may result in the device's failure to provide defibrillation shock which could result in delay or failure to resuscitate the patient.
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
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