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 29 March 2005, SEBIA withdrew from the market batches 28064/01, 28064/02, 28064/03, 28064/04 of the in vitro diagnostic medical device CAPILLARYS IMMUNOTYPING reference 2100 following the identification of the specificity of a lot of anti-Ig M used, which can lead to an erroneous diagnosis of biclonal gammapathy when there is only one monoclonal immunoglobulin .. This device is used for the detection and characterization of monoclonal proteins ( immunotyping) in human serum by capillary electrophoresis in the automatic system CAPILLARYS .. The company has directly notified the recipients of the offending lots by means of the message attached (29/03/2005) (63 KB) validated by Afssaps. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance 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The company BOSTON Scientific has withdrawn from the market on July 6, 2007 the batches and the references specified in the attached message, of the medical device called "CAPIO sutures" manufactured by the company TELEFLEX Medical following a risk of early breakage of the suture and detachment of the tapered needle. The company has directly notified the recipients of the offending batches with the help of the attached message (06/07/2007) (19 KB) This information is intended for health facility directors and local correspondents for materiovigilance for dissemination. where appropriate, to the departments concerned The competent European authorities concerned shall be informed of this measure by the distributor.
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
BMD (BioMedical Diagnostics) withdraws from the market batches 030101 and 030102 (per.31.10.03) of the in vitro diagnostic medical device called CARDIOLISA IgG - references HM 001; HM 001A and HM 004, following the possibility of obtaining false positive results. This device allows the assay of anti-cardiolipin autoantibodies (anti-phospholipid antibodies) of class IgG, in human serum or plasma by immunoenzymatic method. These antibodies are sought especially in the context of thromboses, lupus (systemic lupus erythematosus, drug-induced lupus ..).
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 BMD (BioMedical Diagnostics) withdraws from the market the lot 030401 (per.31.01.04) of the in vitro diagnostic medical device called CARDIOLISA IgG - references HM 001; HM 001A and HM 004, following the possibility of obtaining false positive results. This device allows the assay of anti-cardiolipin autoantibodies (anti-phospholipid antibodies) of class IgG, in human serum or plasma by immunoenzymatic method. These antibodies are sought especially in the context of thromboses, lupus (systemic lupus erythematosus, drug-induced lupus ..).
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 batch 737021301 (06/04/2001 expiry) of the reagent called CHOLESTEROL CALIBRATOR - reference 62473 of the Company BIOMERIEUX SA is withdrawn from the market, because of the reduction of the cholesterol level of the calibrator, without clinically significant incidence on the patients' 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.
Notas adicionales en la data
Acción
The company Edwards Lifesciences has withdrawn from the market on July 07, 2006 lot 58220388 of the medical device called carotid silicone carotid balloon reference T3103AS following an error of presentation of the device compared to the reference product (the product may contain a control valve instead a faucet on the inflating line of the balloon) .. The company has directly notified the recipients of the offending lot with the message attached (07/07/2006) (23 KB) validated by Afssaps. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination, where appropriate 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
The BOSTON SCIENTIFIC INTERNATIONAL company withdrew from the market on March 20, 2007, 136 batches of the medical device called "Carotid Wallstent Endoprosthesis with Monorail release system", references and lot numbers specified in the appendix, following 3 complaints reporting a problem of force the company has directly notified the recipients of the incriminated batches by means of the enclosed message (20/03/2007) (33 KB) validated by Afssaps This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for dissemination, where appropriate, to the services concerned.The competent European authorities concerned 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
Afssaps was informed of two product recalls carried out on December 17 and 18, 2003 by Boston Scientific. The product recall on December 17, 2003 is for all batches of all CAROTID WALLSTENT OTW carotid stent references. It follows the occurrence, in Europe, of 2 cases of detachment of the tip of the stent delivery system. No incidents have been reported in France. The recall on December 18, 2003 is for all lots of all EASY WALLSTENT vascular stent references. It follows the occurrence, worldwide, of 15 cases of detachment of the tip of the stent delivery system. No incidents have been reported in France. The health institutions concerned by these reminders received the enclosed letters (12/01/2004) (20 KB). The other competent European authorities have been informed of these measures 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
Boston Scientific has withdrawn from the market on July 6, 2006 several lots of some references (06/07/2006) (53 KB) of the medical device called "Carotid Wallstent TM Monorail TM - carotid artery stent" following 26 reports reporting unable to rinse the device when purging the instrument .. The company has directly notified the recipients of references and batches concerned with the message attached (06/07/2006) (20 KB) validated by the Afssaps. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for dissemination, where appropriate 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
The B-Braun Aesculap company informed Afssaps on August 6, 2003 that it was recalling four Caspar screws references, following the discovery of a possible loss of sterility of these devices due to a deterioration of their packaging .. The recalled references are. FF 904 SB, lots 51178772, 51183381, 81228436, 81230684. FF 905 SB, lots 51176439, 51185061, 81224373, 81225979, 81227161, 81230937, 81232034, 81232035. FF 909 SB, lot 51183380. FF 912 SB, lots n 51172034, 51179282, 51179970, 81231467 .. The company B-Braun has distributed in France only the reference FF 905 SB and warned the five user centers concerned the recall initiated by means of the attached letter (06/08/2003 ) (11 KB)
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 GAMBRO / HOSPAL has withdrawn from the market on August 28, 2006 batches 0618, 0621, 0622 of the reference 6186886 and lot 0616 of the reference 6184071 of the medical device called "CASSETTE HOSPAL C3" following 5 reports of hemolysis occurred during of the use of this device. The company directly notified the recipients of the incriminated lots with the enclosed message (30/08/2006) (137 KB) validated by Afssaps. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination, where appropriate 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
In agreement with Afssaps, the company Hycel withdrew on 05/02/2004 a batch of the performance control CBC-3K and Dianatrol AQ manufactured by R & D Systems for hematology cytology machines, following the highlighting of bacterial contamination that can lead to erroneous values for certain parameters. The users of this device concerned by this defect, in France, received the attached mail (05/02/2004) (14 KB). The competent European authorities have been informed of this measure by Afssaps. 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
In agreement with Afssaps, the company Medtronic, informed the 21/12/2007, the users of the spinal implant CD Agile horizon of the recall of this implant and recommendations concerning implanted patients. The users concerned in France have received the following letter (26/12/2007) (31 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Orthopedic tray - Product Code OJH
Causa
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Acción
Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.
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 Biorad informed, on 04/07/06, the users of antibiotic discs Céfalotine, the withdrawal of a lot at the origin of a misdiagnosis of resistance. The users of the device concerned by this defect, in France, received the attached mail (04/07/2006) (23 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
In agreement with Afssaps, the company bioMérieux, informed, on May 16, 2007, the users of the device Céfinase allowing the rapid detection of ß-lactamase, the recall of a batch following a labeling error of the cartridge containing the disks. The users of this device concerned by this defect in France have received the following letter (16/05/2007) (38 KB) The competent European authorities have been informed of this measure by the manufacturer. laboratory managers, directors of health establishments and local correspondents of reactovigilance for diffusion to the concerned biological 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
Afssaps was informed by OXOID of the withdrawal of the market, on March 14, 2005, from lot 368726 of the in vitro diagnostic medical device known as the Cefpodoxime + clavulanic acid reference CT1596B disk set due to a lack of antibiotic concentration that could lead to a defect of detection of broad spectrum ßlactamases .. The company has directly notified the health facilities concerned with the attached message (14/03/2005) (76 ko) .. This information is intended for those responsible laboratories, the directors of health establishments and the 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 batch OE146R (péremption15 / 05/2001) of the reagent called disks of CEFTAZIDIME 30mcg (code 66308) of the company BIO-RAD is withdrawn from the market, some cartridges of the batch containing 50 disks not impregnated with ceftazidime (risk of rendering results of false resistance to ceftazidime).
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 Abbott Diagnostic Company requests the discontinuation of the "low level" control present in the in vitro diagnostic medical device boxes called Cell Dyn 26 Controls - references 01H71-01 and 02H43-01 / lot CD034 (per.30.04. 04) due to possible bacterial contamination; this contamination leads to a hazy appearance or visible haemolysis of the product and parameter values out of specification (invalidation of the series of results). This device is a haematological quality control of whole blood to check the accuracy and reproducibility of results for blood count and leukocyte count parameters; it consists of a "low level" control, a "normal level" control and a "high level" control.