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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
"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."