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 20, 2004, Roche Diagnostics informed Afssaps of a withdrawal from the market of batch 23717731 (per 31.12.05) of the in vitro diagnostic medical device called Reflotron® GPT - reference 10745138, produced on October 12, 2004 , following the demonstration by the control laboratory of the supplier, of an anomaly of certain strips leading to the obtaining of erroneous results. The company Roche Diagnostics has directly informed the recipients of the offending lot by means of the attached message (20/10/2004) (7 KB) (not validated by Afssaps). This message is addressed to the directors of establishments health directors, laboratory directors and 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.
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Acción
CIS BIO INTERNATIONAL withdraws lot 10B (expiry 01/10/2003) from the market of the in vitro diagnostic medical device called RENIN III GENERATION, following a calibration defect which leads to an overestimation of the patient results of the order of 20%. This device is a kit for the radioimmunometric assay of active renin in human 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.
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Acción
On 29/03/2008, the company Perugia Plastie Company withdrew from the market the batches of the references contained in the attached message of the medical device called composite matrices for dermal regeneration RENOSKIN, manufactured by Perouse Plastie. This withdrawal follows a few cases reporting difficulties rehydrating the matrix detected during a prospective follow-up on these medical devices. In the event of recent implantation of a device whose hydration would not have been optimal, a risk of slowing or absence of colonization of the matrix could be observed locally and generate a potential risk of localized infection. Perouse Plastie has directly notified the recipients of the incriminated lots with the enclosed message (01/04/2008) (30 ko) validated by Afssaps. This information is addressed to the directors, correspondents of materiovigilance, plastic surgeons and pharmacists responsible for sterile medical devices 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.
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Acción
Additional information. Marketing cessation of contact lens care solutions ReNu MoistureLoc®, Bausch & Lomb company (03/06/2008) (81 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
Afssaps has been informed by MEDTRONIC of the recall of all RF Enhancr and Enhancr NTC catheters. The 6 user centers concerned received the attached mail (04/12/2002) (14 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
Afssaps has been informed of the implementation of a recall made by the company SEPPIM. The affected users have received the attached mail (05/04/2011) (38 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 STRYKER France has withdrawn the lots, specified in the attached message, the medical device called "right and left UNIX blade guide" references E03005013L and E03005013R (manufactured by the company PORTE) following the highlighting of devices engraved with a wrong reference (error between the 2 references E03005013L / left and E03005013R / right) .. These blades are used for the installation of knee prostheses UNIX .. The company has directly notified the recipients of the incriminated lots using of the attached message (25/07/2006) (24 ko) validated by Afssaps. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary with the services concerned. .. This reminder only concerns 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.
Notas adicionales en la data
Acción
The lots 002000, 003000, 004000 of the reagent called SAFETY-TEST ABO / reference 79059 of the company DIAGAST are withdrawn from the market following the presence of PTU-AB card / reference 79054, batch 032000 among their constituents; this batch 032000 having been withdrawn on December 7, 2000.
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 09/11/07, the users of the reagent Salicylate for Synchron system of the withdrawal of a batch of reagent for lack of stability .. The users of this device concerned by default, in France, have received the following letter (14/11/2007) (74 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
On October 11, 2005, Beckman Coulter withdrew from the market and stopped the commercialization of the 844110032 (2.0ml) and 844110033 (0.5ml) medical in vitro diagnostic devices called Sample Buckets, given that the dead volume of these devices last does not correspond to the specifications. The company has directly notified the recipients of the offending references by means of the attached message (13/10/2005) (33 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
DADE BEHRING withdraws from the market batches 231071002 (per 08.09.01), 231086002 (per 23.09.01), 231141002 (per 17.11.01) and 231143002 (per 19.11.01) of the reagent called Stratus CS / TestPak Cardiac Troponin I - ref. CCTNI, following a high background resulting in an increase in the results with possibility for normal samples, to exceed the threshold value (0.06ng / ml).
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
On August 31, 2005, BIORAD removed from the market the serial numbers between 11500 and 71000 of batch 5003901 of the in vitro diagnostic medical device called Scangel Monoclonal ABO / RH reference 86426. This decision follows the identification of a weak (+ to +) non-specific reaction in the anti-A well. This device is a test intended for carrying out the ABO globular test and for determining the RH1 (D) antigen. It combines the principles of agglutination and gel filtration .. The company has directly notified the recipients of the offending batch by means of the attached message (31/08/2005) (59 KB) validated by Afssaps. The European Competent Authorities concerned are informed directly by the manufacturer. 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
On October 22, 2004, the company Medex Medical withdrew from the market the references and batches specified in the attached list (25/10/2004) (9 ko) in annex of the medical device called "Secure System" and "Kids Kit" site sampling due to a risk of development of fracture lines in the body of this site, which can weaken the whole and cause dislodgment of the septum .. No report has been reported in Europe to date. The Medex Medical company warned the users directly with the attached message (25/10/2004) (12 KB) validated by Afssaps. This information is addressed to the directors and local correspondents of materiovigilance for diffusion to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer. list of references and lots (25/10/2004) (9 ko message Medex Medical (25/10/2004) (12 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 lots: n ° 250499 and n ° 022699 of the reagent called: SECURICARD (references IJB 109010224 / IJB 109010124), of INSTITUT JACQUES BOY company are withdrawn from the market following a weakening of the anti-A antibody of this device of control pre-transfusional, leading to a possibility of misinterpretation of the test.
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 064999, 131100, 140700, 170300, 171600, 180700, 224799, 240400, 280900 of the reagent called SECURICARD 1 pocket-reference 109010224; batches 205199, 215199 of the reagent called SECURICARD 3 bags -reference 109010124; batches 240400, 294399 of the reagent called PHYSIOCARD 1 pocket-reference 109012124 and batch 024499 of the reagent called PHYSIOCARD 3 pockets -reference 109012224 of the company INSTITUT JACQUES BOY are withdrawn from the market, following a weakening of the anti-A antibody of these devices (cards) pre-transfusion control, causing a decrease in the intensity of the agglutination reaction leading to a misinterpretation of the test.
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 25 and 26/01/2011, the company HOSPIDEX France (MSH group) has withdrawn from the market all batches of the reference of the medical devices called ALCO PREP LARGE (ref 610) and ALCO PREP MEDIUM (ref. by TRIAD Group (USA) on behalf of H & W (B-3384 GLABBECK Belgium), following the discovery of contamination of these products by the bacterium Bacillus cereus Hospidex France (MSH Group) has directly notified the recipients of the incriminated batches by means of the enclosed message validated by Afssaps (03/02/2011) (1794 kb) This information is intended for directors and correspondents of materiovigilance for distribution if necessary The competent European authorities concerned are informed of this measure by the company H & W (Belgium) Read also Alcohol stamps and wipes of the company Triad Group: Potential contamination by a bacterium (03/02/2011) - Comm Alcoholic buffers in training kits for Kogenate - Bayer Health Administration (03/02/2011) - Safety Information. Alcoholic buffers in administration kits for injection of Extavia - Novartis Pharma (03/02/2011) - Safety information. Alco Prep alcoholic buffers in Lutrelef 3.2 mg administration kits, powder and solvent for solution for injection (03/02/2011) - Safety Information. Alco Prep Alcoholic Pads in ViraferonPeg and Introna Boxes (03/02/2011) - Safety Information. Alcohol swabs in injection kits of Stelara 45 mg - Janssen Cilag (03/02/2011) - Safety information
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 PRODIMED has withdrawn from the market on May 25, 2007 the batches specified in annex (25/05/2007) (13 KB) of the medical device called "Seldiflex and Seldicuff long-term catheters" following 6 cases of separation between the luer- lock and the catheter tube. The company has directly notified the recipients of the incriminated lots with the message attached (25/05/2007) (14 ko) validated by the Afssaps. This information is addressed to the directors of health facilities, pharmacists and local correspondents for materiovigilance for dissemination, where appropriate, to the departments concerned. The relevant European Competent Authorities are informed of this measure by the respective distributors.
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 Science et Médecine informed Afssaps on September 17, 2003 that it was recalling batches of SEM III titanium femoral prostheses manufactured between January 1997 and March 2001. The attached letters were sent by the company Science et Médecine to orthopedic surgeons and local correspondents for material vigilance of the 88 health establishments concerned. The references and lot numbers of the recalled devices appear on the list attached to these letters. This file is currently being assessed by Afssaps. The surgeons concerned were directly informed of the progress of the investigations conducted by the Afssaps. Courrier de l'Afssaps (22/10/2003) (52 KB) Courrier de Science et Médecine (15/09/2003 ) (58 KB) Courrier de Science et Médecine (17/09/2003) (74 KB List of batches of devices recalled (21/10/2003) (793 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
Lots 121100 and 030301 of the reagent called SERAFOL cards (pre-transfusion control cards) - ref. BG1704, BIOTEST are withdrawn from the market due to a possible defect in the packaging that may cause a lack of reactivity of the dried antibodies constituting the cards.
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 STRYKER company has withdrawn from the market on May 15, 2007 batches 06361AE2 to 07044AE2 of the medical device called "Serfas electrodes 90 3.5 mm with suction" reference 0279351100 used in arthroscopy following a risk of short circuit related to a liquid leak at the level of the handpiece. The company has directly notified the recipients of the incriminated lots with the message attached (15/05/2007) (23 KB) validated by Afssaps. This information is addressed to the directors of health establishments, local correspondents of materiovigilance and pharmacists 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
Afssaps has been informed of the implementation of a batch recall carried out by Medpro. The users concerned have received the attached mail (30/05/2011) (560 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
As part of its vigilance competence for the products for which it ensures safety, the Agency has reassessed the sensitivity of all HIV-1 antibody test reagents in accordance with protocol approved by the Advisory Committee for the Registration of Reagents. In view of the results of this re-evaluation and following the opinion of the Advisory Committee on the Registration of Reagents (CCER), the French Agency for the Safety of Health Products decided to withdraw from the market of six reagents on 16 June 1999 (message from June 17, 1999). In addition to these decisions, the Agency decided on 9 November 1999 to proceed with the removal of the SERODIA HIV and SERODIA HIV1 / 2 reagents from BAYER DIAGNOSTICS, given the impossibility of improving the performance of these reagents, including sensitivity was close to the acceptance criteria adopted by the CCER.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
All batches of reagents referred to as. "Triclonal total human albuminous anti-D (RH1) serum test (Euclone IgG + IgM)" Ref: 910006, 910022. "Euclone human polyclonal Anti-D (RH1) test serum" - Ref: 910031, 919314 and included in Ref : 910032, 919347. "Euclone polyclonal Anti-E (RH3) test serum" Ref: 910036, 919333. "Euclone human polyclonal anti-e (RH5) test serum" Ref: 910038, 915418. "Test serum Anti-E Euclone human polyclonal c (RH4) "Ref: 910037, 915411." Anti-Kell (K1) plate and human polyclonal Coombs Euclone test serum "Ref: 910040, 915442." Negative control for albuminous Euclone polyclonal "Ref: 910042, 919319 and included in Ref: 910032, 919347. "IgA kit - Chlamydia Panel IFI" Ref: 900580 and "Conjugate Anti IgA ADUAL" Liquid (man, mouse) - Chamydia Panel IFI "Ref: 900169 of the company EUROBIO are withdrawn from the market These reagents have not been registered in accordance with Article L.761-14-1 of the Public Health Code at the Agence du médicament. A reagent can not be used to evaluate the reagent's performance and reliability criteria, which can lead to risks to public health.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
The company ServiBio informed Afssaps of the withdrawal of lot 29104-05 of the In Vitro Diagnostic Medical Device called SERVIRapide MULTIPARAMETER 4-M-AMP references KD637 and KD737 .. This decision follows the possibility of obtaining false negative results . This device is a one-step solid-phase immunochromatographic test for the detection of Cannabis, Morphine, Cocaine and Methamphetamine in the urine. 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 05 September, Cook informed AFSSAPS that it was recalling several batches of expandable metal biliary stents. AFSSAPS has not been reported to have a materiovigilance incident concerning these devices in France. The attached letter (23/09/2003) (51 KB) was sent to the 52 user centers, at the following address: intention of local correspondents of materiovigilance September 01, 2003