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.
Extra notes in the data
Advice regarding the use of the device. 3rd Party Publications
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.
Extra notes in the data
If necessary, customers should use the telephone 0800-26-4848 or the email contato@sa.biomerieux.com to get in touch with Biomerieux Brasil SA. Anvisa's Technovigilance Unit is monitoring this case.
Reason
The manufacturer company verified that some strains of the acinetobacter baumannii microorganism present "sensitive" final results for the susceptibility test carried out on the vitek 2 xl and vitek 2 compact systems, against the antibiotic amicacin; in the presence of reference methods, such strains present "resistant" final results.
Action
The company Biomerieux Brasil SA has informed that it has sent letters of communication to the clients involved, instructing the users of the cited products to carry out alternative methodology before releasing the result (s) of susceptibility test (s) antibiotic / antigen ratio Amicacin x Acinetobacter baumannii.
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.
Extra notes in the data
Abbott Vascular is initiating a voluntary Field Safety Corrective Action for the HT Connect Guide Wires peripheral wire family because a small number of devices present a partial lamination of the PTFE coating. To date, the frequency of reported incidents was 0.08%. Although no long-term or irreversible effects have been reported in patients, the potential risks associated with coating lamination include: embolism, thrombus and occlusion of the peripheral veins. Abbott Vascular research is underway and there is no definite root cause identified for inadequate adhesion of PTFE coating to some guidewires. During continued research, Abbott Vascular is identifying improvements in the coating process to ensure adhesion of PTFE coating. As the event was reported on a low frequency but randomly distributed among the manufactured batches that were distributed since the product's overseas launch in September 2011, Abbott Vascular requests that customers identify and return all HI family wires -TORQUE CONNECT GUIDE WIRE not used, regardless of batch number. #### Update (02/18/2014): According to a report sent by the company, 454 units of the product have already been collected until the date of 02/13/2014.
Reason
Possibility of partial lamination of the ptfe coating, with risk of embolism, thrombi and occlusion of the peripheral veins.
Action
Abbot Vascular is collecting the product from the market. Check your inventory and segregate the identified risk products. Contact the company for return purposes.
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.
Extra notes in the data
Action
All lots of the reagents called "MULTI-4 CO-OXIMETER CONTROL" and "CMV IHA AUTO", from the company INSTRUMENTATION LABORATORY are withdrawn from the market. These reagents have not been registered in accordance with Article L.761-14-1 of the Public Health Code at the French Medicines Agency. The lack of registration of a reagent does not allow its services to evaluate the performance criteria and reliability of the reagent, which can lead to risks to public health.
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.
Extra notes in the data
Action
All batches of reagents referred to as. "Triclonal total human albuminous anti-D (RH1) serum test (Euclone IgG + IgM)" Ref: 910006, 910022. "Euclone human polyclonal Anti-D (RH1) test serum" - Ref: 910031, 919314 and included in Ref : 910032, 919347. "Euclone polyclonal Anti-E (RH3) test serum" Ref: 910036, 919333. "Euclone human polyclonal anti-e (RH5) test serum" Ref: 910038, 915418. "Test serum Anti-E Euclone human polyclonal c (RH4) "Ref: 910037, 915411." Anti-Kell (K1) plate and human polyclonal Coombs Euclone test serum "Ref: 910040, 915442." Negative control for albuminous Euclone polyclonal "Ref: 910042, 919319 and included in Ref: 910032, 919347. "IgA kit - Chlamydia Panel IFI" Ref: 900580 and "Conjugate Anti IgA ADUAL" Liquid (man, mouse) - Chamydia Panel IFI "Ref: 900169 of the company EUROBIO are withdrawn from the market These reagents have not been registered in accordance with Article L.761-14-1 of the Public Health Code at the Agence du médicament. A reagent can not be used to evaluate the reagent's performance and reliability criteria, which can lead to risks to public health.
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.
Extra notes in the data
Action
The batches 40868M300, 42623M200, 43658M100, 44002M100, 44524M200, 44870M200, 45085M100, 45436M300, 45878M200 and 48729M200 of the called reagent "AxSYM PROGESTERONE" Ref: 7A64-20, of the laboratory ABBOTT DIAGNOSTIC are withdrawn from the market, following a risk of erroneous result .
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.
Extra notes in the data
Action
Following the observation of the decrease of its sensitivity, lot 8J 025 U of the reagent called "PASTOREX RUBELLA Ref 72924", of SANOFI DIAGNOSTICS PASTEUR company is withdrawn from the market. It is requested to retest the samples found negative with this lot.
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.
Extra notes in the data
Action
The batches of standard anticoagulant tubes of the LES brand of SAYAG LES, whose references and batch numbers follow, are withdrawn from the market. Quality problems may render them, in whole or in part, unfit for their use and must not be used. The results obtained from the samples taken on these tubes are likely to be erroneous. Standard LES CITRATE anticoagulant tubes (potential presence of heparin, reference number CLVV05 / CLVV05NF / LES0221P 180207XX9x 190207XX9x 220207XX9x 230207XX9x 240207XX9x 250207XX9 .. LES2036N 250203XX9x 240203XX9x
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.
Extra notes in the data
Action
Batches KXTN-1152, KXTN-1162, KXTN-1167, KXTN-1172, KXTN-1192, KXTN-1199 and KXTN-1201 of the reagent referred to as "STRATUS TROPONINE I", ref B5700-64 of the company DADE BEHRING are removed from market following a risk of a false increase.
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.
Extra notes in the data
Action
The lot AA0011 of the called reagent, "Phenobarbital Dimension Reagent (PHNO)", code DF60, ADM No. E02141 of the company DADE BEHRING is withdrawn from the market following a risk of erroneous result.
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.
Extra notes in the data
Action
The batch numbers beginning with: 1702, 1802, 1902, 2202, 2302, 2402, 2502, 2602 concerning standard serum anticoagulant serum beads tubes, references: TB05PP, TB05PPNF and TB20PP of SAYAG LES are withdrawn from the market more the finding of a quality defect that could lead to erroneous results.
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.
Extra notes in the data
Action
The batches 49001M100, 51758M300 and 51585M300 of the reagent called "IMx ESTRADIOL" ref: 2215-22 of the ABBOTT FRANCE company are withdrawn from the market following a risk of lowered result for the samples whose estradiol level is higher than 1000 pg / ml.
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.
Extra notes in the data
Action
As part of its vigilance competence for the products for which it ensures safety, the Agency has reassessed the sensitivity of all HIV-1 antibody test reagents in accordance with protocol approved by the Consultative Commission for the Registration of Reagents. In view of the results of this re-evaluation and after consulting the Consultative Commission for the Registration of Reagents, the French Agency for the Safety of Health Products has decided to withdraw from the market the following reagents. Innotest HIV Ab 1.0.2. (ref: K1076 / K1077) of the INGE Company. Murex ICE HIV-1.0.2 (ref: 100A / 150A / 200A) from MUREX DIAGNOSTICS and DIASORI Companies. Cobas Core anti-HIV-1 / HIV-2 EIA DAGS (Ref: 756059) of ROCHE DIAGNOSTIC. HIV 1 + 2 Double Check (ref: 332000) from the companies PBS ORGENICS and ORTHO CLINICAL DIAGNOSTIC. Multispot HIV-1 / HIV-2 (ref: 72269) from SANOF. and Genie II HIV-1 / HIV-2 (ref: 72323) DIAGNOSTICS PASTEUR
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.
Extra notes in the data
Action
As part of its vigilance competence for the products for which it ensures safety, the Agency has reassessed the sensitivity of all HIV-1 antibody test reagents in accordance with protocol approved by the Consultative Commission for the Registration of Reagents. In view of the results of this re-evaluation and after consulting the Consultative Commission for the Registration of Reagents, the French Agency for the Safety of Health Products has decided to withdraw from the market the following reagents. Innotest HIV Ab 1.0.2. (ref: K1076 / K1077) of the INGE Company. Murex ICE HIV-1.0.2 (ref: 100A / 150A / 200A) from MUREX DIAGNOSTICS and DIASORI Companies. Cobas Core anti-HIV-1 / HIV-2 EIA DAGS (Ref: 756059) of ROCHE DIAGNOSTIC. HIV 1 + 2 Double Check (ref: 332000) from the companies PBS ORGENICS and ORTHO CLINICAL DIAGNOSTIC. Multispot HIV-1 / HIV-2 (ref: 72269) from SANOF. and Genie II HIV-1 / HIV-2 (ref: 72323) DIAGNOSTICS PASTEUR
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.
Extra notes in the data
Action
The batch 721630901 of the reagent denominated "CHLORITEST ref 62573", the company BIOMERIEUX is withdrawn from the market because of a defect of stability.
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.
Extra notes in the data
Action
Due to the risk of erroneous results due to quality defects, all batches of traditional LABVAC brand vacuum and LABVAC brand sampling tubes containing additives from the company "FRAMOPLAST" are withdrawn from the market.
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.
Extra notes in the data
Action
Lots: 52735 M300 / 301, 53053 M200 / 201/202, 53446 M100 / 101, 53577 M100 / 101, 54885 M100 / 101, 54887 M100 / 101, 54889 M100 / 101, of the reagent referred to as "AxSYM TROPONINE-I", ref. 3C29-20, of the company "ABBOTT DIAGNOSTIC", are withdrawn from the market following the demonstration of a decline in stability resulting in a calibration failure and an increase in the values of controls and patients.
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.
Extra notes in the data
Action
Lots 904312, 905246, 906507, 907441 and 908161 of the reagent called "AMPLIFIED MYCOBACTERIUM TUBERCULOSIS Direct test" (ref: 39006) of the company BIO MERIEUX are withdrawn from the market following a risk of false-negative result by inhibition of the reaction of amplification on some samples.
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.
Extra notes in the data
Action
Lot 53784Q100 of the reagent called "HCG Totale Controls" (ref 9C21-10) from ABBOTT Diagnostic is withdrawn from the market following a possible increase in the values of the controls beyond the specifications indicated in the instructions for use.
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.
Extra notes in the data
Action
The lots . M99092, M99103, M99106, M99118B and M99132 of the reagent called i-STAT EG6 + (Ref HPM3602A). K99091, K99105, K99106 and P99159 of the reagent called i-STAT G3 + (Ref HPM3603A). M99085 and M99086 of the reagent called i-STAT EG7 + (Ref HPM3601A). are withdrawn from the market due to early deterioration of the PO2 sensor system leading to the absence of PO2 results or excessively high PO2 results.
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.
Extra notes in the data
Action
Lot ABE747A of the reagent called "ORTHO BIOVUE SYSTEM ANTI A, ANTI B, ANTI AB, ANTI D, ANTI CDE: monoclonal control" (ref 707190) of the company ORTHO CLINICAL DIAGNOSTICS is withdrawn from the market following a risk of false results positive of the negative control, preventing any validation of the results obtained with the reagent cassette.
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.
Extra notes in the data
Action
As part of its vigilance competence for the products for which it ensures safety, the Agency has reassessed the sensitivity of all HIV-1 antibody test reagents in accordance with protocol approved by the Advisory Committee for the Registration of Reagents. In view of the results of this re-evaluation and following the opinion of the Advisory Committee on the Registration of Reagents (CCER), the French Agency for the Safety of Health Products decided to withdraw from the market of six reagents on 16 June 1999 (message from June 17, 1999). In addition to these decisions, the Agency decided on 9 November 1999 to proceed with the removal of the SERODIA HIV and SERODIA HIV1 / 2 reagents from BAYER DIAGNOSTICS, given the impossibility of improving the performance of these reagents, including sensitivity was close to the acceptance criteria adopted by the CCER.
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.
Extra notes in the data
Action
The batches 47107M200 (6C48-25), 49672M100 (6C48-25) and 50665M200 (6C48-30) of the reagent denominated "ARCHITECT T3 FREE" (Reference: 6C48-25 / -30), of the ABBOTT DIAGNOSTIC company are withdrawn from the market , due to a possible decrease in high control values related to a microparticle defect in the reagent.
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.
Extra notes in the data
Action
The batches 731 406 301, 726 440 901, 736 137 701, 728 682 901, 737 692 801 of the reagent called ASL SLIDEX-ref 7234, from the company BIOMERIEUX SA, are withdrawn from the market because of a decrease in sensitivity that can lead to the absence of agglutination of certain samples (false negatives possible).
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.