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 24/10/07, the company TORNIER withdrew from the market medical devices called femoral stems revision, reconstruction or recovery - TORNIER whose precise names, batches and references are specified in the attached reminder message. This recall follows a risk of leakage at the packaging that may compromise its integrity and sterility of the product. The company TORNIER has directly notified the recipients of the incriminated lots with the message attached (25/10/2007) (25 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
On 02 June 2005, the OLYMPUS company withdrew from the market lot 2934 (per 01/09/2005) of the in vitro diagnostic medical device called Ferritin reference OSR6150 following the detection of a microbial contamination resulting in a degradation of the analytical performance of this batch over time .. This device is used in the quantitative determination of ferritin in human serum OLYMPUS analyzer. The determination of serum ferritin is a sensitive indicator of iron stores in the body. The company has directly notified the recipients of the offending batch by means of the attached message (02/06/2005) (12 KB) validated by The relevant European Competent Authorities are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the departments 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 November 23, 2007, the company CARDINAL HEALTH sent to the institutions concerned, the attached message (27/11/2007) (85 KB) validated by Afssaps, relating to gluteal fields with graduated pocket contained in kits delivery. Indeed, the graduation of the blood loss collection pocket is erroneous and leads to an undervaluation of these losses. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. concerns only France.
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
General surgery tray (kit) - Product Code LRO
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 Afssaps, the company Dade Behring, on 23/08/07, proceeded to the withdrawal of a lot of the reagent Flex Bilirubin Totale. The users of this device concerned by this defect in France have received the following letter (23/08/2007) (15 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
On March 24, 2006, DADE BEHRING withdrew EJ6174 - FG6180 - CB6192 - FM6210 - CP6224 from the market for the in vitro diagnostic medical device called Flex Cocaine Reagent Cartridge on Dimension - Reference Analyzers DF 92A following the Highlighting. a decrease in the sensitivity of the technique at the level of the threshold value. This device is used for the detection of the urinary metabolite of cocaine .. The company DADE BEHRING directly warned the recipients of the incriminated lots by means of the attached message (24/03/2006) (20 KB) validated by the Afssaps . The competent European authorities concerned are informed directly by the manufacturer. 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
On April 3, 2006, the company Dade Behring withdrew from the market batches DE6347 (per 13/12/2006) and CG7003 (per 03/01/2007) of the in vitro diagnostic medical device called Flex reagent cartridge CKMB Mass (MMB) reference RF420. This device is a test to quantitatively measure the creatine kinase MB (CKMB) isoenzyme in human serum and plasma on the Dimension clinical chemistry system. This measure is motivated by quality control results that may have a negative bias of 19% to 45% and checks on patient samples have shown a negative bias of 15% to 25% that can occur with quality controls located in the expected values. The company has directly notified the recipients of the offending batches by means of the attached message (03/04/2006) (17 KB) validated by Afssaps. This information is intended for laboratory managers, the directors of health and to the correspondents of reactovigilance for diffusion, if necessary, 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
DADE BEHRING withdraws CE3151 lot (per 31.05.03) from the market for the in vitro diagnostic medical device called: Flex Troponin I cardiac reagent size / cartridge (CTNI) - reference RF421C, following the risk of obtaining results overexposed exceeding the recommended limit (0.1 ng / ml) for acute coronary syndrome risk stratification. This device is used for the determination of cardiac troponin I in serum and heparinized plasma on the Dimension analyzer.
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 6, 2005, Dade Behring removed the lots from the market. CF5285 (12/10/2005). EJ5294 (21/10/2005). EG5300 (per 27/10/2005). CJ5336 (02/12/2005). EF5306 (02/11/2005). BP5316 (12/11/2005). BA5326 (02/11/2005). DH5341 (07/12/2005). DE5348 (14/12/2005). FJ5356 (22/12/2005) ,. of in vitro diagnostic medical device called Flex® C-Reactive High Sensitivity Protein Cartridge (RCRP) reference DF34 .. This decision follows the identification of a stability problem with the consequence of an inability to calibrate the method, either results with error messages, or imprecision or random accuracy of patient results and quality controls. This device is used for the quantitative determination of C-reactive protein in serum and heparinized plasma. on the Dimension® clinical chemistry system .. The company has directly notified the recipients of the offending lots by means of the enclosed message (06/06/2005) (13 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 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
The BOSTON Scientific company has withdrawn from the market on December 12, 2005, all batches of references cited in the appendix (12/12/2005) (82 KB), medical devices called Flextome Cutting Balloon Monorail System and Peripheral Cutting Balloon microsurgical dilation device This measurement follows reports of separation of the distal sheath of the Monorail catheter from the device during intervention on patients. The company has directly notified the recipients of the offending lot with the message attached (12/12/2005) (102 KB) validated by the Afssaps. This information is intended for the directors of health facilities and to the local correspondents of materiovigilance for diffusion, if necessary to the services concerned. The competent European authorities concerned shall be 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 Beckman Coulter, informed, on 07/06/2007, the users of Flow-Count Fluorosphères reagent used in flow cytometry for the determination of the absolute values of the cell populations analyzed, the recall of a lot due to a lack of performance. The users of this device concerned by this defect in France have received the following letter (11/06/2007) (32 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
Future Medical Systems informed Afssaps on 03 October 2003 that it has recalled the FMS reference 4114 interfaces used in knee arthroscopy procedures. The company STRYKER, the only distributor in France of this device sent to the 21 establishments concerned on October 9, 2003 the attached mail (09/10/2003) (1253 ko).
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 Ciba Vision has withdrawn from the market on July 26, 2006 several batches of the medical device called Focus DAILIES Toric following the highlighting of lenses labeled with an incorrect power .. The company has directly notified the recipients (26/07/2006) (95 ko) (ophthalmologists, opticians, wholesalers) of the incriminated lots with the attached message (26/07/2006) (95 KB) validated by Afssaps. The relevant European Competent Authorities are informed of this measured 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 Bio-Rad informed, on 26/07/2007, the users of Fosfomycin cartridges 50 μg of the withdrawal of several batches. The users of this device concerned by this defect, in France, have received the enclosed mail (30/07/2007) (21 KB) At the European level, only France is concerned by 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
ABBOTT DIAGNOSTIC withdraws from the market batches 95881Q100 and 95881Q101 (expiry date 11 February 2004) of the in vitro diagnostic medical device called Free T4 Controls (9C03-10) and lot 01550Q100 (October 28, 2003 expiry) of the device called T4 Free Reagent IMx (2222-20) due to values outside the expected limits on AxSYM or IMx. Only on IMx, the simultaneous use of these batches of controls and reagent can result in a decrease in patient results up to 30% of their value with controls within the expected limits. These devices are used in the microparticulate immunoenzymological assay (MEIA) for the quantitative measurement of free thyroxine in serum or human heparinized plasma.
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 April 12, 2005, CIBA Vision removed from the market batches 116417, 120450, 082869 of the medical device called FreshLook Radiance Moonlight Soft Lenses due to possible differences between the actual power and the power indicated on the labeling of the packaging (- 2.75D on the label while the actual power is + 3.00D) .. The company has directly notified the recipients of the incriminated lots with the message attached (12/04/2005) (47 KB) validated by Afssaps .. The European competent authorities concerned are informed directly 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 Randox on 18/09/06 recalled a batch of Fructosamine control, due to an alteration of the concentration of this parameter. The users of this device concerned by this defect, in France, received the attached mail (18/09/2006) (111 KB). 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
PORGES withdrew from the market on July 25, 2006 the lots F011, F012, F013, F014, F015, F016, F017, F018, F019, F020, F021, F022, F023, F024, F025, F026, F027, F028, F029. , F030 of the medical device referred to as "Furlow Introducer" reference QB5555 following Keith needle lock (supplied in separate delivery kit) in the introducer slot. The company has directly notified the recipients of the incriminated lots with the message attached (25/07/2006) (23 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 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
On 29/11/2005, the company IPSOGEN SAS withdrew the lot 05-04-01 (per 03/2006) from the in vitro diagnostic medical device called FusionQuant® Kit m-bcr reference FQPP-09-CE. This device is used for real-time Quantitative PCR analysis of the m-bcr Transcript in bone marrow or peripheral blood samples of patients with Acute Lymphocytic Leukemia or Ph-positive Chronic Myeloid Leukemia. m-bcr fusion has already been diagnosed. This measure follows the discovery of a defect in the stability of this batch resulting in the production of a standard ABL curve (for the control gene). ABL) having an upper slope and intercept in absolute value than the reference values, this invalidating the series of assays. The company has directly notified the recipients of the offending batch by means of the attached message (29/11/2005) (25 KB) validated by Afssaps. This information is intended for laboratory managers, the directors of establishments health and to the correspondents of reactovigilance for diffusion, if necessary, to the services concerned.