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, and as a precaution, the company ADVANCED BIONICS decided to voluntarily recall the Clarion cochlear implants with positioner, references AB-5100 H11 and AB-5100 H12, and sent the enclosed mail (23 / 07/2002) (72 ko), informing the heads of otolaryngology departments and the correspondents of materiovigilance of the institutions concerned with this measure. Afssaps also issued recommendations. to implant centers for cochlear implants.
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 Becton Dickinson withdraws from the market lot 1225152 (per.01.08.02) of the in vitro diagnostic medical device called BBL Crystal Rapid Stool / Enteric ID Kit - reference 245050, following the possibility of obtaining false positive results for patients. tests carried out with the substrate IPH (indoxyl phosphate), including with the quality control strain Pseudomonas aeruginosa ATCC 27853 (expected to be negative IPH). This test allows the identification of Gram-negative Enterobacteriaceae (Enterobacterioceae and Vibrionaceae) by a miniaturized method employing modified chromogenic and conventional substrates.
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 December 5, 2005, BD Diagnostics removed from the market the batches listed in the attached message, in vitro diagnostic medical devices called BBL GasPak Pouch System reference 260651 and BBL GasPak CamyPouch System reference 260656. devices are pocket systems generating either an atmosphere adapted to the culture of anaerobic bacteria, or an atmosphere adapted to the culture of microaerophilic bacteria. This decision follows the detection of a bacterial contamination of the liquid reagent sachets contained in the aforementioned systems .. The company has directly notified the recipients of the offending lots by means of the message attached (05/12/2005) (69 KB) validated by 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
In agreement with Afssaps, the company BD Diagnostics informed, on 12/09/06, the users of the BBL Staphyloside test the withdrawal of two lots for lack of performance. The users of this device concerned by this defect, in France, received the attached mail (12/09/2006) (21 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for distribution to the concerned biology departments.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
In agreement with Afssaps, the company Dade Behring informed, on 20/07/04, the users of three batches of the BC Thrombin reagent of erroneous results for the samples presenting heparin. The users of this device concerned by this defect, in France, have received the following letter (23/07/2004) (9 ko). The competent European authorities have been informed of this measure by the manufacturer. This information is intended for laboratory managers , to the directors of health establishments and local correspondents of reactovigilance for diffusion to the biological 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
Becton Dickinson withdraws from the market. lot 4028645 (version 03.06.05) of the in vitro diagnostic medical device called BD BACTEC ™ MGIT ™ 960 SIRE Kit - reference 245123. batch 4076878 (version 23.06.05) of the in vitro diagnostic medical device known as the BD BACTEC ™ MGIT ™ 960 INH Kit 0.4 - reference 245126. batch 4076881 (version 23.06.05) of the in vitro diagnostic medical device called BD BACTEC ™ MGIT ™ 960 EMB 7.5 kit - reference 245127. following evidence of fungal / mold contamination of the BD BACTEC ™ MGIT ™ 960 SIRE / lot 3351099 supplement included in the above listed kits; this contamination can lead either to invalid results (positive growth control before 4 days), or, potentially, to a false interpretation of resistance to the anti-TB drugs tested. These devices are used for the rapid detection of the sensitivity of Mycobacterium tuberculosis to antimycobacterial agents. (streptomycin, isoniazid, rifampicin, ethambutol).
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, 2004, Becton Dickinson withdrew from the market lot 4154541 (per 15.10.05) of the in vitro diagnostic medical device called BD BACTEC ™ MGIT ™ 960 SIRE Kit - reference 245123, following the identification of any mushroom / mold contamination of the BD BACTEC ™ MGIT ™ 960 SIRE supplement / lot 41400062 included in the above-mentioned package. Becton Dickinson directly informed the recipients of the offending lot by means of the enclosed message ( 23/11/2004) (14 KB). The competent authorities have been notified directly by the manufacturer. This information is addressed to the directors of health establishments and correspondents of reactovigilance for diffusion, if necessary, with the services concerned .. Message Becton Dickinson (23/11/2004 ) (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
Following the batch recall on BD Beaver Mini Blad blades. On January 8, 2007, BECTON DICKINSON informed Afssaps that 6 new lots were affected by this recall. The new list is attached. (17/01/2007) (28 KB) The company has directly notified the recipients concerned by these new lots.
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 BECTON DICKINSON has withdrawn from the market on January 8, 2007 the batches of the references specified in the appendix, of the medical device called "BD Beaver Mini Blade blades" following a risk of lack of sealing at the packaging that may compromise sterility of the product. The company has directly notified the recipients of the references and the incriminated lots by means of the attached message (09/01/2007) (25 KB) validated by Afssaps. This information is addressed to the directors, pharmacists and local correspondents of medical equipment vigilance of health institutions, for dissemination, where appropriate to the services concerned. The relevant European Competent Authorities are 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
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
In agreement with Afssaps, Becton Dickinson has withdrawn 5 lots of BD Difco Sallmonella / Shigella Antiserum reagent corresponding to 4 different product references on 01/06/06. The reagent has solution difficulties and / or reduced or no reactivity. The users of this device concerned by this defect, in France, received the attached mail (05/06/2006) (31 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
The company Becton Dickinson France has withdrawn from the market on July 8, 2005, the batches of the references specified in the appendix (08/07/2005) (54 KB), medical devices called "BD DTX Plus pressure monitoring kits". This decision follows the risk of detachment of the mobile part of the valve when it is actuated, resulting in leakage. The company has directly notified the recipients of the incriminated lots with the message attached (08/07/2005) (26 KB) validated by the Afssaps. This information is intended for the directors of health facilities and to the local correspondents of materiovigilance for dissemination, where appropriate 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
Erratum concerning the recall of batches from 01/09/2003 of BD Hydrocath / BD Careflow central venous catheters / BD Exacta introductory kits. Two corrections must be made to the summary table of the batch numbers concerned. In the Hydrocath ™ product range. Ref: 681060, to add the following lot number: 21002. Ref: 681118, replace the lot number 210019 by the 21101. Replace the reference 680168 by the reference 681068 .. The corrected table attached (01/09/2003 ) (13 KB) concerning all these references was updated on 04/09/2003.
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 January 21, 2005, BECTON DICKINSON withdrew from the market all the references and batches of medical devices called BD Hydrocath, BD Careflow, BD Secalon Seldy and BD Percactaneous Introduction Catheters after the risk of packaging. imperfectly sealed compromising the sterility of the product. The company has directly notified the recipients of the references and batches concerned with the attached message (21/01/2005) (176 KB) validated by Afssaps. This information is intended for pharmacists and local correspondents of materiovigilance for dissemination, if necessary, to all the services concerned. The relevant European Competent Authorities are 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
in vitro diagnostic - Product Code PPM
Causa
Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (hrp) dispensers (part of the iview, ultraview and optiview detection kits, as well as cintec plus cytology kit) and with hematoxylin ii.
Acción
On Dec 19th all Roche affiliates (the direct consignees) worldwide were notified via Safety Board Notification (SBN) and subsequent Field Safety Notification (EX-US) and UMDC TD00090 (US) SBN and FSN revised Dec 20th due to 3 affected part numbers missed on original letter.
The instructions are as follows:
"Actions taken by Roche Diagnostics
All affected product has been placed on hold. Ventana has reworked all product in its inventory and is in the process of manufacturing new lots for distribution and replacement of customer affected kits. Customers will be notified when corrected product is available.
Actions to be taken by the customer/user
Affected kits may continue to be used by customers until corrected product is available, however Ventana is mandating that the affected IHC detection kits (iView, ultraView, OptiView) must only be used in conjunction with same-slide controls. These controls must be appropriate for each assay and capable of detecting false negative results due to a complete or partial reagent dispense failure. CINtec PLUS Cytology does not have the capacity for same slide controls, so system-level controls should be maintained. ultraView SISH Detection is used for HER2 analysis, and employs internal positive controls; no external control is required. For assays that directly relate to clinical therapy decision making (e.g. ER/PR, HER2, ALK, etc.), it is additionally important to select a same slide positive control tissue with sufficient sensitivity to detect small decreases in intensity that may cause borderline positive cases to appear as negative (e.g. HER2 2+ vs. 1+). Although the use of same slide controls is considered optimal laboratory practice and strongly recommended by Ventana, customers may revert to standard run controls once non-impacted product is received.
In order to reduce the risk of this issue impacting patient care, customers not using same slide controls as a standard practice should follow their
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 Becton Dickinson has withdrawn from the market on April 6, 2007, the batches specified in the recall message of the medical device called "BD Microtainer Safety Flow lancets" references 366354, 366355 and 366358 following a risk of separation of the blade of the body of the lancet when activating the device. The company has directly notified the recipients of the incriminated lots by means of the enclosed message validated by Afssaps. (10/04/2007) (59 kb.) This information is intended for the directors of health establishments or analytical laboratories and correspondents of material vigilance for dissemination, where appropriate to the services concerned. informed of this measure by the manufacturer.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
The company BECTON DICKINSON has withdrawn from the market on November 28, 2005, the references and batches specified in the appendix of the medical devices called "BD Perisafe kits and BD Durasafe kits" following some defective batches of connectors contained in these kits and which could lead to a problem of screwing. These kits are devices for epidural anesthesia. The company has directly notified the recipients of the incriminated lots with the message attached (28/11/2005) (25 KB) validated by the Afssaps. This information is addressed to the directors of health facilities, pharmacists and local vigilance correspondents for dissemination, where appropriate 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
Following the investigations carried out as part of the withdrawal on February 10, 2004, BECTON DICKINSON withdrew from the market on February 25, 2004, lots 3170526 of reference 360212 and lots 3148757; 3170482; 3170497 and 3289348 of the reference 360213 of the medical device called BD Precision Glide needles. These withdrawals follow an increase in the number of cases where the needle and the body of sample, usually associated, dissociate during a blood sample. The manufacturer has directly notified the users 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 has directly notified the recipients of the offending lots by means of the attached message (26/01/2005) (23 KB). 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 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 July 5, 2005, the Becton Dickinson Diagnostic Company withdrew from the market batches 4345728 (per 30.11.2005) and 4345733 (per 31.12.2005) of the in vitro diagnostic medical device called BD ProbeTec CT / AC kit reference 440474. This decision follows the identification of a risk of an increase in the number of false positive Chlamydia trachomatis results. This device allows the direct qualitative detection of Chlamydia trachomatis DNA from endocervical samples, urethral swabs. in humans and male and female urine samples, as evidence of C. trachomatis infection. The company has directly notified the recipients of the offending lots by means of the enclosed message (08 / 07/2005) (13 KB) validated by Afssaps. The European competent authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, plant managers health authorities and to the correspondents of reactovigilance 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 August 11, 2005, Becton Dickinson withdrew the batch 22561 of the in vitro diagnostic medical device called BD Procount, reference 340498, following the demonstration of a low resolution of CD34 + and CD45 + events on the new bottles. and started which results in a failure of the control analysis and obtaining an error message. In this case, if a manual analysis is performed, it may prove to be unsuccessful and may lead to an undervaluation of the number of CD34s. This device is used for the counting of hematopoietic stem cells. The company has directly notified the recipients of the offending lot by means of the message attached (11/08/2005) (56 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
In agreement with Afssaps, the Becton Dickinson company has recalled, on August 16, 2006, a batch of BD Procount reagent following the loss of stability of this lot. The users of this device concerned by this defect, in France, received the attached mail (16/08/2006) (84 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for distribution to the concerned biology departments.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
In agreement with Afssaps, the company Becton Dickinson informed, on January 29, 2007, the users of the BD Procount reagent used for the hematopoietic stem cell count, the recall of a batch due to a problem of stability. The users of this device concerned by this defect, in France, have received the enclosed letter (29/01/2007) (30 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
In agreement with the AFSSAPS, the company Becton Dickinson informed, on 17/04/2007, the users of the BD Procount reagent used for the hematopoietic stem cell count, batch recall and recommendations following stability problems. The users of this device concerned by this defect, in France, have received the attached mail (19/04/2007) (33 KB). The competent European authorities have been informed of this measure by Afssaps. This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for distribution to the concerned biology departments.
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.
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.