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.
Notes supplémentaires dans les données
Action
The ANSM has been informed of the implementation of a lot withdrawal carried out by the company RADIOMETER .. The users concerned have received the attached mail (29/07/2015) (214 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.
Notes supplémentaires dans les données
Action
The ANSM has been informed of the implementation of the withdrawal of a lot made by the Cepheid company. The concerned users received the attached mail (16/03/2016) (82 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.
Notes supplémentaires dans les données
Action
ANSM has been informed of the implementation of a lot withdrawal carried out by Radiometer. The users concerned have received the attached mail (25/02/2016) (32 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.
Notes supplémentaires dans les données
Action
Afssaps has been informed of the implementation of a recall made by the manufacturer DERM TECH France and its distributor LIFE PARTNERS EUROPE .. The users concerned have received the attached mail (08/09/2011) (28 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.
Notes supplémentaires dans les données
Action
ANSM has been informed of the implementation of the batch recall carried out by DIASORIN. The users concerned received the attached mail (04/09/2012) (695 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.
Notes supplémentaires dans les données
Action
The ANSM has been informed of a recall made by the company Dexther of tips, hoses, regulators and flowmeters placed on the market between 17/02/2017 and 01/09/2017 .. The users concerned have received the mail ci -Joint (27/09/2017) (125 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.
Notes supplémentaires dans les données
Action
In agreement with Afssaps, the Biotrin company, informed on 04/12/2008, the users of the Trichinose reagent manufactured by the company IVD Research, the withdrawal of a batch. The users of this device concerned by this withdrawal, in France, have received the attached mail (05/12/2008) (15 KB). This information is intended for laboratory managers, health facility managers and local reactovigilance correspondents for dissemination to the relevant 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.
Notes supplémentaires dans les données
Action
In agreement with Afssaps, the company DiaSorin, informed the 27/10/2008, the users of the reagent Toxo Liaison IgG avidity II of the withdrawal of several batches. The users of this device concerned by this withdrawal, in France, have received the enclosed mail (30/10/2008) (71 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.
Notes supplémentaires dans les données
Action
Afssaps was informed on 08/07/2010 of the implementation of a security action carried out by the company DiaSorin SA. The users concerned have received the attached mail (21/07/2010) (58 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.
Notes supplémentaires dans les données
Action
Afssaps has been informed of the implementation of the three-batch recall carried out by DIASORIN. The affected users have received the attached mail. (01/03/2012) (702 KB)
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.
Notes supplémentaires dans les données
General surgery tray (kit) - Product Code LRO
Cause
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Action
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.
Notes supplémentaires dans les données
Action
DIASORIN has informed the users of the ETI-dsDNA reagent that two lots have been withdrawn. The users concerned, in France, have received the attached mail (21/06/2013) (55 KB). This information is addressed to the directors of health establishments and local correspondents of reactive vigilance for diffusion to the concerned 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.
Notes supplémentaires dans les données
Action
DIASORIN has informed the users of the ETI / ANA / ENA 8 Profile reagent of the withdrawal of a batch. The users concerned, in France, have received the attached mail (21/06/2013) (244 ko). This information is addressed to the directors of health establishments and local correspondents of reactovigilance for diffusion to the concerned 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.
Notes supplémentaires dans les données
Action
ANSM has been informed of the implementation of the batch recall carried out by DIASORIN. The users concerned have received the attached mail (12/07/2013) (63 KB). This information is addressed to the directors of health establishments, the local correspondents of reactovigilance and the medical biologists.
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.
Notes supplémentaires dans les données
Action
The company DIASORIN sent to the users of the ETI / ANA / ENA 8 Profile rectifier rectification of the batch number concerned by the recall implemented in June 2013. The users concerned, in France, received the email attached (19/08 / 2013) (56 KB). This information is addressed to the directors of health establishments and local correspondents of reactive vigilance for broadcasting to the services concerned. Read too. ETI / ANA / ENA 8 Profile reagent - DIASORIN - Batch removal
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.
Notes supplémentaires dans les données
Action
The company DIASORIN has informed the users of the Liaison XL Murex HBsAg Quant reagent for the implementation of the recall of three batches. The users concerned, in France, have received the attached mail (19/09/2013) (74 KB). This information is addressed to the directors of health establishments and local correspondents of reactive vigilance 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.
Notes supplémentaires dans les données
Stapler, Surgical - Product Code GAG
Cause
Latching mechanism failure.
Action
The recalling firm issued a recall letter dated 6/30/03 to their accounts informing them of the recall and the need to return the product.
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.
Notes supplémentaires dans les données
Action
The ANSM has been informed of the implementation of the recall of four lots carried out by DIASORIN. The users concerned received the attached mail (29/10/2013) (73 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.
Notes supplémentaires dans les données
Action
ANSM has been informed of the recall of two batches of DIASORIN Liaison Control Anti-HBc reagent. The users concerned have received the attached mail (26/12/2013) (70 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.
Notes supplémentaires dans les données
Action
ANSM has been informed of the implementation of a recall made by DiaSorin. The users concerned received the attached mail (03/10/2014) (747 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.
Notes supplémentaires dans les données
Action
ANSM has been informed of the implementation of a recall made by DIASORIN. The users concerned have received the attached mail (27/11/2014) (752 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.
Notes supplémentaires dans les données
Action
The ANSM has been informed of the implementation of a recall made by the company DiaSorin .. The users concerned have received the attached mail (23/07/2014) (68 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.
Notes supplémentaires dans les données
Action
On December 28, 2007, the company DIDACTIC removed from market the 2007J01, 2007J15 and 2007E30 batches of the reference TL 99N of the medical device called syringes DIDACTIC 60 ml L / L, following reports reporting outbreaks of nuisance alarms on certain shoot -Seringues, inaccuracies in volumes taken and leaks .. The company DIDACTIC directly notified the recipients of the incriminated lots with the enclosed message validated by Afssaps (02/01/2008) (116 KB). This information is addressed to the directors of establishments, pharmacists and local correspondents of materiovigilance for dissemination if necessary to the services concerned. This recall concerns only France.
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.
Notes supplémentaires dans les données
Action
In agreement with Afssaps, the company Didactic, informed the users, on the 26/01/09, the recall of umbilical clamps of Bar. The users concerned, in France, received the attached mail (27/01/2009) (20 KB). This information is addressed to the directors of health establishments, local correspondents of materiovigilance and pharmacists for diffusion to the concerned 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.
Notes supplémentaires dans les données
Action
Afssaps has been informed of the implementation of a recall carried out on 16/02/2011 by DIXI Microtechniques. The users concerned have received the attached mail (07/03/2011) (20 KB).