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
In agreement with Afssaps, the company Dade Berhing proceeded, on March 14, 2007, to the recall of 3 batches of Dimension Flex Troponin I cardiac reagent following a lack of performance. Users of this device concerned by this defect in France have received the following letter (14/03/2007) (35 KB) The competent European authorities have been informed of this measure by the manufacturer
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 DADE BEHRING withdraws from the market the batch 1FD012 (per 01.06.02) of the reagent Dimension PALB Calibrator / ref. DC50, due to the possibility of calibration failure (upper part of the nonlinear calibration curve) leading to an impossibility to issue results for the patient 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.
Notas adicionales en la data
Acción
XC0285 lots; HA0224; GA0197 of the reagent called: Dimension Protein C Reactive - reference DF37 of the company DADE BEHRING S. A are withdrawn from the market, following an inaccuracy intra- and inter-tests (coefficient of variation ranging from 10 to 20%).
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 GA1205 lot of the reagent called Dimension® / Flex ™ Lipase Reagent Cartridge (LIP) - Ref.DF55A from DADE BEHRING SA is withdrawn from the market due to erroneous results with certain cartridges: lower values of the controls and patient 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.
Notas adicionales en la data
Acción
On 24/11/2005, the company Dade-Behring withdrew from the market lot 5FD038 (per 01/06/2006) of the in vitro diagnostic medical device called Calibrator Dimension® PBNP reference RC423. This device is a calibrator for the calibration of the PBNP method, for the quantitative determination of the N-terminal proBNP (natriuretic peptide type B) in human plasma on the Dimension® clinical chemistry system. A previous withdrawal dated November 3, 2005 occurred on lot 5BD009 for a stability defect of the PBNP Calibrator resulting in a positive bias on the quality control values after recalibration and as a consequence an overestimation of the patient results. Following this previous withdrawal and new reports, the validity of the Calibrator before opening has been redefined at 5 months and therefore lot 5FD038 has reached this new validity limit. The company has directly notified the recipients of the offending lot by means of the attached message (24/11/2005) (19 KB) validated by Afssaps. The relevant European Competent Authorities are informed directly by the competent authority of the United Kingdom, MHRA .. This information is intended for laboratory managers, directors of health establishments and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.
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
On 28 June 2005, the company Dade-Behring withdrew lots 5BD812 (28.08.2005), 5DD820 (18.10.2005), 5CD813 (07.09.2005) and 5DD821 (25.10.2005). ), 5CD816 (dated 28.09.2005), 5DD828 (dated 11.10.2005), 5DD817 (dated 04.10.2005) of the in vitro diagnostic medical device called Dimension® QuickLYTE Integrated Multisensor reference S600 .. This decision follows the possibility of obtaining results of urinary chlorine (patient and quality control) having a positive bias of 10 to 50%. This device is used for the quantitative measurement of sodium, potassium, chlorine and total carbon dioxide in serum and heparinized plasma and to the quantitative measurement of sodium, potassium and chlorine in the urine. The company has directly notified the recipients of the offending lots by means of the attached message (28/06 / 2005) (12 KB) validated by Afssaps .. The relevant European Competent Authorities are informed directly by the manufacturer. This information is intended for laboratory managers, directors of health establishments and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.
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
Batches YM1331 (per.27.11.01) and LM1355 (per.21.12.01) of the so-called Dimension® reagent / reagent cartridge Flex ™ Ethyl Alcohol (ALC) - reference DF 18 - from DADE BEHRING SA are withdrawn from the market following the possibility of obtaining erroneous results: lowering the values of the controls and the patient 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.
Notas adicionales en la data
Acción
On 3 April 2006, the company OXOID SA withdrew from the market batches 437930 (per 28/02/2009), 437982 (per 28/02/2009) and 437984 (per 28/02/2009) of the medical device in vitro diagnosis called Disks of Imipenem for antibiogram reference CT0455B following the detection of an instability of the antibiotic load that could lead to a risk of rendering a result falsely resistant to Imipenem .. The company warned directly recipients of the incriminated lots by means of the attached message (03/04/2006) (15 KB) validated by Afssaps. This information is intended for laboratory managers, directors of health establishments and correspondents of reactive vigilance for dissemination, where appropriate, to the services concerned.
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
On 17/11/2005, TECAN informed Afssaps of the withdrawal of lots U122098L-1325, U122098L-3225 and U122098L-2325 from the in vitro diagnostic medical device called Disposable Tips 1000 μl with filter reference 612 513.1. These are tips for Tecan Genesis .. reagents / sample dispensers. This measurement follows the discovery of a tip defect (presence of two filters instead of one) that may cause reactive sampling problems. / sample resulting in false negative or positive results. The company notified the users directly on 17/11/2005, by means of the attached message (25/11/2005) (16 KB). users, no tip of the aforementioned lots was used in the context of a diagnosis. Therefore, this withdrawal does not require patient-specific measures. The relevant European Competent Authorities are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health establishments and health and safety correspondents. dissemination, where appropriate, to the services concerned.
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
Schiller Medical withdraws from the market batches bearing the expiry dates between August 2004 and November 2004 of the medical device called collapsible defibrillation electrodes - reference W1410241, manufactured by UnoMedical / Maersk / Niko, related to its FRED defibrillators, following several reports of malfunctions. These malfunctions seem due to poor aging of the electrodes due to the fragility of their packaging bag. A note. : the lots concerned by this recall are easily recognizable by the white color of the packaging bags; the customers concerned are directly notified by Schiller.
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 SEDAT company has withdrawn from the market on October 27, 2006, the batches of the references specified in the annex of the medical device called "DOLPHIN inflation system" following a risk of blockage of the pressure gauge needle contained in this device, which would then cause a incorrect display of pressure. This system is used to inflate the balloon of an angioplasty catheter. The manufacturer has directly notified the recipients of the incriminated batches with the enclosed message (27/10/2006) (56 KB) validated by the This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. The European competent authorities concerned are informed of this measure by Afssaps.
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
Sedat informed AFSSAPS of a reminder it issued on 11 April 2003 concerning Dolphin inflation systems for balloon catheters. Sedat sent the attached mail (05/05/2003) (136 KB) on April 11 to the 17 user centers and 2 vending companies, for the attention of pharmacy services.
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 GIFRER-BARBEZAT laboratories, in agreement with Afssaps, proceed as a precautionary measure, to the withdrawal of the batches of the products mentioned in the appendix (31/10/2008) (14 ko) following the highlighting during the 'an inspection, conditions of manufacture do not allow to bring all guarantees in terms of infertility. No claim has been reported to date in connection with this finding.
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
On June 30, 2005, the company ALL DIAG withdrew from the market the batch DOA5030060 of the in vitro diagnostic medical device called DRUGCHECK reference 5456. This decision follows the detection of non-compliant labeling on the cassettes. Indeed, the sequence of the various narcotics recorded on the tape is wrong, resulting in a possibility of rendering a false positive result for a given narcotic and falsely negative for a second .. This device is a rapid test of simultaneous detection of a panel of The company has directly notified the recipients of the offending batch by means of the attached message (30/06/2005) (12 KB) validated by Afssaps. The competent authorities concerned is informed by Afssaps. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.
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 BAXTER company withdraws from the market lot 05290106 the topical / surgical manual vaporizer medical device reference B2232000999999 following a signal of detachment of the spray nozzle of this device during its use and the potential risk for the patient in case this separation occur during a surgical procedure, since the spray tip is not radiopaque. This device is used for the application of fibrin glue .. Description of the incident: risk of detachment of the spray tip of this device during its use .. Consequences or risk: risk of loss of the tip at the level of the wound because it is not radiopaque .. Given the reduced number of recipients of this lot, they were warned directly by the laboratory .. Therefore, no alert number n 'has attributed to this withdrawal.
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
In agreement with the AFSSAPS, the company CONTROLE GRAPHIQUE, following several incidents of materiovigilance, decided to proceed to the withdrawal of the plates concerned and sent the attached mail (12/06/2002) (6 KB), informing of this measure the directors and correspondents of materiovigilance of the establishments concerned.
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
In agreement with Afssaps, the Diagast company, informed the 04/12/2007, the users of the reagent DuoLys used for the grouping ABO-RH1 and the phenotyping RH-Kell of the human red blood cells, of the withdrawal of a lot. The users of this device concerned, in France, have received the attached mail (06/12/2007) (19 KB) .. The competent European authorities have been informed of this measure by the manufacturer. This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for distribution to the concerned biology departments.
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 DIAGAST withdraws from the market batches 303000 and 304000 (March 2005) of the in vitro diagnostic medical device called DUOMICRO - reference 79750 (ready-to-use reagents in microplate for ABO-RH grouping and RH-K phenotyping), following reports of decreased activity of anti-e (RH5) / clones MS16 + MS63 leading to false negative results for e (RH5) antigen. This device corresponds to microplates of 96 U-bottom wells in which pre-deposited and pre-dried reagents (monoclonal antibodies, negative control) were taken; it makes it possible to determine the presence of erythrocyte antigens A and / or B, D (RH1), C (RH2), E (RH3), c (RH4), e (RH5) and K (KEL1) on the surface of red blood cells. to note: the investigations carried out so far by the laboratory Quality Control Diagast, did not lead to the reproduction of these anomalies.
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
On October 30, 2007, Baxter SAS withdrew from the market batches 07B070 and 07B071 references 1500950 and 1500951 of the medical device called Duploject Easy Prep, manufactured by Baxter Healthcare Corporation, following an incomplete soldering of the product packaging. The company BAXTER SAS has directly notified the recipients of the incriminated lots with the message attached (30/10/2007) (32 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.
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
Bayer Diagnostics withdraws lots 23937 from the market; 26596; 27297 (per 25.06.03) and 29634 (per 30.07.03) of the in vitro diagnostic medical device known as: ADVIA Centaur Toxo M 1, 2 / reference 03089388 quality control (formerly ref. of stability resulting in out - of - specification quality control results (invalidation of the assay series). This device is involved in the determination of anti - toxoplasm IgM antibodies performed on ADVIA Centaur machines.
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
Lots 56568M200; 58332M200; 60275M300; 60278M300; 57411M200; 59545M200; 60276M300 of the reagent called IMx Hemoglobin Glyqué - reference 1A86-88 of the company ABBOTT DIAGNOSTIC are withdrawn from the market following the appearance of error messages ("******" or "<3,61% GHb") and / or possible inaccuracy of results for some samples (less than 1% of cases).
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
Abbott Diagnostic withdraws lot 05102I2 (per.30.11.04) from the market for the in vitro diagnostic medical device known as cell Dyn reticulocyte reagent - reference 3H40-01, after observing that this device may cause out-of-specification background noise. This anomaly is detected during the required "reticulocyte background" procedure prior to any reticulocyte assay (in accordance with the Operator Manual and the Cell Dyn Reticulocyte Reagent Record) and precludes assaying. This device allows counting of reticulocytes on fresh blood samples, on Cell Dyn 3200, 3500 and 3700 analyzers.
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 BRAHMS France withdraws from the market batches 302712 (per.05.06.03), 302715 (per.03.07.03) and 302717 (per.16.07.03) of the in vitro diagnostic medical device called DYNOtest anti-TGn - references 27.1 and 27.5, due to a lack of "coating" in human anti-thyroglobulin autoantibodies of the tubes used in the composition of the kits. This defect leads to obtaining overestimated results (of the order of 15 to 30 IU / ml). This device makes it possible to assay the anti-thyroglobulin antibodies in human serum by a radioimmunological technique by competition.
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
In agreement with AFSSAPS, Adhésia Laboratoire is recalling the Segufix support belts, references SG00, SG01 and SG 02, which are not equipped with lateral straps attached to the belt following several serious incidents of materiovigilance. The users of these seat belts were informed on 26 July 2004 of this reminder by the attached letter (26/07/2004) (194 KB). This recall follows a notification by the competent German authority ( Bfarm) .. This information concerns the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services in particular the services of geriatrics and psychiatry.
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
On October 1, 2004, Advanced Bionics® removed the implanted CLARION 1.2®, CLARION CII EAR® and HIRES ™ 90K Implantable Cochlear Stimulators from the market, following the identification of a few stimulators with moisture levels above tolerances and could lead to malfunctions of these devices .. The company Advanced Bionics® has directly notified the implant centers of the products concerned by this recall using the message attached (05/10/2004) (28 KB) validated by the This message is accompanied by a recommendation Afssaps (01/10/2004) (16 KB). The competent European authorities concerned are informed of this measure by the European representative.