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.
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.
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.
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.
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.
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.
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.
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.
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
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: 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.
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.
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
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).
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.
"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."
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.
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.
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.
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.
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.
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.