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, Siemens DPC on 09/03/07 recalled a batch of Immulite TNF alpha reagent due to a lack of performance. The users of this device concerned by this defect, in France, received the attached mail (09/03/2007) (91 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
In agreement with Afssaps, the Siemens company has published, on 06/07/2007, recommendations to users of the TnI Ultra reagent used for the quantitative determination of cardiac troponin I. The users of this device concerned by this defect, in France, have received the following letter (10/07/2007) (74 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is intended for laboratory managers, managers health establishments and local correspondents of reactive vigilance for diffusion to the biology services concerned .. See also. Update on Tnl-Ultra reagent - SIEMEN. of 28/09/2007
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 Siemens, informed the 26/09/2007, the users of the reagent TnI-Ultra used for the quantitative determination of cardiac troponin I, the availability of optimized batches allowing to lift the recommendations broadcasted on 06/07/2007. . This measure is accompanied by the withdrawal of the batches in use, concerned by the recommendations of 06/07/2007. The users of this device concerned by this information, in France, have received the enclosed letter (28/09/2007) (98 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 Olympus company proceeded, on 21/02/07, to the recall of 7 batches and to the reduction of expiry of 4 lots of Total Bilirubin reagent, following a change of aspect of the reagent. The users of this device concerned by this defect, in France, received the attached mail (21/02/2007) (52 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
Lot 53784Q100 of the reagent called "HCG Totale Controls" (ref 9C21-10) from ABBOTT Diagnostic is withdrawn from the market following a possible increase in the values of the controls beyond the specifications indicated in the instructions for use.
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 OSSUR company has withdrawn from the market on March 25, 2006 the numbers of series mentioned in the attached table (21/04/2006) (13 KB) of the medical device called Total Knee Knee models TK1100, TK1900, TK2000 and TK2100 following the presence Defective fastenings on certain Total Knee knee elements. OSSUR informs that the Total Knee knee device must be replaced even if it does not cause any discomfort to the patient in order to avoid a risk. injury or destruction of other elements of the prosthesis .. This information is for orthopedists (functional rehabilitation centers) and local correspondents of materiovigilance for dissemination, where appropriate to the services concerned .. The company has directly notified the recipients of the incriminated series using the enclosed messages (information to the recipients of the mentioned lots (21/04/2006) (12 KB) & information gén erale Ossur (21/04/2006) (13 Kb)). The competent authorities of the countries 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
In agreement with Afssaps, the company bioMérieux has, on 13/11/2006, recalled several lots of reagent TPHA 100 following the reduction of the title of the positive control (R3) contained in these kits. The users of this device concerned by this defect, in France, have received the attached mail (13/11/2006) (24 KB). This information is intended for laboratory managers, health facility managers and local reactovigilance correspondents for dissemination to the relevant biology departments.
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
Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.
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
Eurobio withdraws 604465 (January 01, 2005) from the market for the in vitro diagnostic medical device known as: TPHA kit - reference SHASYP00-8T, following the presence of agglutinates in certain test red cell suspension vials, resulting in loss of sensitivity that can lead to false negative results. As a precautionary measure, in agreement with Afssaps, Eurobio asks biologists to reconsider all syphilis serodiagnostics concerned by this batch (present on the French market since September 10, 2003). A note. : in the case of a negative test, the notice advises to complete the profile of the results by practicing a RPR / VDRL-Coal on the sample. This device allows the detection and the titration of the antibodies anti-Treponema pallidum within the framework serodiagnosis of syphilis.
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 Eurobio informed, on February 13, 2004, the users of the TPHA kit for the detection of anti-Treponema pallidum antibodies (serodiagnosis of syphilis), the removal of two lots with a sensitivity defect susceptible to give false negative results. Health facilities, as well as the EFS concerned by this withdrawal, received the attached letter (13/02/2004) (82 KB). The competent European authorities have been informed of this measure by Afssaps.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
In agreement with Afssaps, the company Ingen has recalled, on 11/09/06, all TQS Reader readers currently available on the market, following the demonstration of a malfunction without consequences for the results to patients. This device is exclusively distributed in Franc. The users of this device concerned by this defect, in France, received the attached mail (13/09/2006) (29 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
The company TYCO HEALTHCARE withdrew from the market on April 5, 2006, the lots whose expiry date is between 2008 and 2010 inclusive (N of lot starting with 2003, 2004 or 2005) of the medical device called "tracheostomy tubes" 8.0 mm TRACHEOSOFT PERC Percutaneous "reference 137-80, following incidents reporting detachment of the locking system of the collar that can allow the cannula to migrate into the trachea .. The company has directly notified the recipients of the incriminated lots using of the message attached (05/04/2006) (188 ko) validated by Afssaps. This information is addressed to the directors of health establishments and 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.
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
On 17 November 2004, Bio-Rad withdrew from the market lot 2144002V (per 01.08.06) of the in vitro diagnostic medical device called TRANSCLONE anti-RH1 (D) FAST M - references 86370 and 86371 .. The company Bio-Rad has directly informed the recipients of the offending batch by means of the attached message (17/11/2004) (19 KB). This information is addressed to the directors of health establishments and correspondences of reactovigilance for diffusion, 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 10, 2007, the company SENDAL France withdrew from the market lot H24746 of the medical device called TRANSFUSEND, manufactured by SENDAL SA, following the detection of a labeling error (11/10/2007) (14 ko ) concerning the CE marking of this device. This information is intended for pharmacists and local correspondents of materiovigilance 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
Afssaps was informed by Olympus on 24/05/07 of the withdrawal of several batches of Triglyceride reagent due to a lack of performance. The users of this device concerned by this defect, in France, have received the attached mail (29/05/2007) (50 kb.) This information is intended for laboratory managers, directors of health establishments and correspondents local reactive vigilance for dissemination to 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.
Notas adicionales en la data
Acción
The company OLYMPUS France withdraws from the market batches 9778, 9779, 9785 of the reference OSR6133 of the in vitro diagnostic device called OLYMPUS Triglycerides following a problem of stability of the enzyme (glycerol kinase) present in the reagent R1 contained in the box . The degradation of this enzyme leads to a slowing of the kinetics of the reaction, the results of the samples having a triglyceride concentration higher than 10 g / l can be affected (decrease).
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 Thermo Fisher Scientific proceeded, on 27/03/07, to the recall of several batches of the Triglycerides reagent, following a lack of performance. The users of this device concerned by this defect, in France, received the attached mail (29/03/2007) (45 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 VECTEC removed from the market on February 19, 2007 the batches 3532, 3534 and 3536 of the medical device called "trocars" respective references 12100H, 12060 and 5100 following non-compliant results of sterility tests performed on samples of the same load sterilization. The company has directly notified the recipients of the incriminated lots with the message attached (21/02/2007) (84 KB) validated by the 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
ABBOTT DIAGNOSTIC withdraws the lots from the market. 91268M300 / 91268M301 (expiry 10 Oct.02). 91269M300 / 91269M301 (Expiration 13 Oct.02) e. 91270M300 / 91270M301 (expiry 17 Oct.02) of the so-called Troponin -I AxSYM reagent / reference 3C29-20, following an increase in the number of apparently healthy patients in the 0.6 to 2.5 ng / ml zone (whereas this population is more generally below the threshold of 0.5 ng / ml). This reagent is used for the determination of cardiac troponin I in serum on the AxSYM 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
Lot 54 TROPONINE Ic reagent (references A110631 / A110632 / A116993 / A116994, used on systems ACS: 180 and ADVIA Centaur) of the company BAYER DIAGNOSTICS was withdrawn from the market, at the initiative of the manufacturer, 04.09 .2000, following the aggregation of the magnetic particles in the solid phase on some cartridges.
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 09 September 2005, the company ServiBio withdrew from the market batches 2005032301 (per 09/2006), 200506903 (per 12/2006) and 2005071001 (per 01/2007) of the in vitro diagnostic medical device called True- Sign hCG reference V9900 (200 tests) following the detection of false negative results. This device is a qualitative first-line test for the detection of hCG in serum and urine, for the biological diagnosis of pregnancy. The company has directly notified the recipients of the incriminated lots by means of the attached message ( 09/09/2005) (15 KB) validated by the Afssaps. This message is completed by a letter Afssaps (09/09/2005) (25 ko) on the modalities to follow for the patients whose hCG screening would have been found negative with the aforementioned lots. 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 BIOMERIEUX withdraws from the market the batch 777044701 (per.27.05.04) of the in vitro diagnostic medical device called VIDAS Quality Control Test - reference 30 500 following the presence of TSH cones in certain bags labeled QCT .. This device allows the Check that the pipetting system of the VIDAS and Mini VIDAS instruments is working properly. A note. : the anomaly causing this recall does not affect the control operation.
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 TERUMO France has withdrawn from the market on December 21, 2005 all batches of references specified in the appendix, the medical device called "Tsunami Gold coronary stents" of 4.0 mm in diameter following a few incidents likely related to a defect of deployment of the balloon. No serious cases have been reported to date in France. The company has directly notified the recipients of the references and the incriminated lots by means of the attached message (21/12/2005) (49 KB) validated by Afssaps. This information is addressed to the directors of health establishments, pharmacists 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
On July 11, 2001, CHIRON BLOOD TESTING removed from the market batches 021087, 022087, 023079, 028092, 029081, 030068, 031099, 033084, 034064, 035062, 120081 of the in vitro diagnostic medical device known as TTC (Ten Tip Cassette). 10-well cassette), reference 104578, used with the Chiron TMA HIV-1 / HCV Assay reagent. This withdrawal is the result of a manufacturing defect (length of some tips below the required specifications) leading to invalid results.