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 27.08.04, Bayer Diagnostics withdrew from the market batches 75 (per 13.12.04) and 78 (per 22.02.05) of the in vitro diagnostic medical device known as ADVIA Centaur CA 19-9 - references 03481938 ( 250 tests) and 04612750 (50 tests) and lot 76 (per 24.12.04) of the in vitro diagnostic medical device called ACS: 180 - references 04412689 (300 tests) and 01569439 (50 tests), following the implementation of evidence of sensitivity to heterophile antibodies potentially present in patient samples larger than that of previous batches; this may lead to higher results than expected. These devices are used for the determination of the CA 19-9 tumor marker on the ADVIA Centaur and ACS: 180 analyzers.
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 boxes containing the cartridges, the number of which appears in the attached table, are removed for the ADVIA® Centaur ™ - T3 reagents (ref.110741, 110742); - Progesterone (ref.118530); FrT4 (ref.110737, 110738); Ferritin (ref.110745, 110746) from Bayer Diagnostics following a problem in the filling line for some of these cartridges. For example, the ADVIA® Centaur ™ - T3 / lots 9055507 and 9055907 reagent packs containing cartridges ranging from 09061 to 09342 and 13449 to 13534 are being removed from the market. cartridges of another number are not removed. Reagent. T. Progesteron. FRT. Ferritin. Reference. . 110741 (80 tests, 110742 (400 tests, 118530 (50 tests, 110737 (50 tests, 110738 (250 tests, 110745, 50 tests, 110746, 250 tests, reagent lot no. incriminated cartridges 905550. 905590. 886158. 886168. 890128. 894538. 896148. 901908. 908858. 908868. 918228. 901143. 901153. 906833. 910753. 912833. 917343. 889952. 889962. 894822 897962. 898712. 901132. .915361. 917321. 917331. 887001. 887011. 889041. 889971. 896101. 901161. 901671. 906141. 889031. 894841. 908761. No. of the incriminated cartridges 09061 to 0934. 13449 to 1353. 01015 to 0109. 02627 to 0270. 04491 to 0457. 06505 to 0658. .. 51006 to 5109. 55271 to 5535. 56587 to 5667. 57479 to 5756. 61540 to 6162. 64716 to 6480. 70777 to 7086. 76185 to 7638. 78013 to 7812. 83605 to 8369. 86221 to 8630. 51210 to 5129. 53558 to 5364. 60263 to 6034. 64914 to 6499. 67018 to 6709. 69680 to 6983. 70336 to 7044. 71979 to 7206. 74903 to 7500. 75751 to 7583. 55544 to 5 562. 56352 to 5657. 68742 to 6884.. . 52538 to 52643. 54809 to 5497. 60453 to 6053. 71425 to 7151. 73532 to 7361. 75440 to 7552. 80912 to 8099. 82652 to 8273.. . . The complete lot number is a 7-digit code located on the reagent box. . **. The cartridge number corresponds to the last 5 digits located on the barcode of the cartridge read by the system.
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
A worldwide recall of AED20 semi-automatic external defibrillators has been implemented due to a risk of dysfunction preventing or delaying unacceptably the delivery of shock by the defibrillator, with a possible failure of the patient's resuscitation. In France, only 20 demonstration devices were concerned by this recall: after multiple searches, 2 devices numbers 205519 and 205520, were not found. As a result and in agreement with Afssaps, the company WELCH ALLYN asks all potential users of these devices, to check if they do not have these 2 serial numbers and to warn if necessary, the company WELCH ALLYN at +33 (0) 1 60 09 33 66. This information is addressed to the directors and pharmacists of health establishments, and to the local correspondents of materiovigilance for dissemination, where applicable to the services concerned. SDIS are also affected by this alert.
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 Transforme, informed, on 09/12/08, the users of the AES ankle prostheses of the suspension of the marketing of this device. The users concerned, in France, have received the attached mail (29/12/2008) (28 ko). A survey conducted by Afssaps, intended to evaluate the rate of geodes and their evolution in patients with AES ankle prostheses, is currently underway. The competent European authorities have been informed of this measure by Afssaps. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services. Read auss. Information / recommendation concerning AES ankle prostheses manufactured by Transystème SA and marketed by Biomet 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
ABBOTT DIAGNOSTIC withdraws from the market lot 96005HW00 (per 17.09.03) of the in vitro diagnostic medical device called ALCYON HDL Direct - reference 8D42-02 following a stability problem that may lead beyond 25.05.03, that is the failure of calibrations, or the obtaining of out-of-specification controls. This device allows the determination of cholesterol / HDL (high-density lipoprotein) on the ALCYON automaton.
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 15/11/07, the company B.Braun removed from the market the medical devices called CASPAR applier for Yasargil mini titanium aneurysm clips - reference FT420T and CASPAR app for Yasargil standard titanium aneurysm clips - referenceFT430T manufactured by AESCULAP AG Co KG, continued to the notification of a case of rupture of the internal cane. The company B.Braun has directly notified the recipients of the offending products with the message attached (16/11/2007) (119 KB) validated by the Afssaps. This information is addressed to the directors and correspondents of material / réactovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
TOSOH BIOSCIENCE withdraws from the market lot H911305 / T (per 30.03.04) of the in vitro diagnostic medical device called AIA PACK ucPA - reference E06-01-5202TB, following the highlighting - during quality checks internals - possibility of drift of the ucPA values of the multi-control AIA-Pack / levels 1, 2, 3; this drift results in an increase of the values beyond the fixed limits. This device allows the determination of the uncomplexed fraction of prostate specific antigen (ucPA) in human serum, on TOSOH AIA SYSTEM analyzers. This assay, in addition to the total PSA assay, may help to discriminate between benign prostatic hypertrophy and prostate cancer.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
On June 28, 2005, Beckman Coulter SA withdrew from the market batches M407255 and M409024 of the in vitro diagnostic medical device called Alcohol Reagent (ETOH) reference 474947 following possible quality control out of limits and calibration discharges before their expiry date. In addition, the expiry dates of lots M412090 and M503108 of the same device are shortened by four months. This device is used with the SYNCHRON LX, the UniCel 600/800 system (s) and the SYNCHRON Systems ETOH Calibrator. It is intended for the quantitative determination of ethanol in serum, plasma, human urine or human whole blood. The company has directly notified the recipients of the offending lots by means of the attached message (30 / 06/2005) (28 kb) validated by Afssaps. The competent European 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
The company ABBOTT DIAGNOSTIC withdraws from the market the batch 82101HW00 (April 2003) of the in vitro diagnostic medical device called: ALCYON / cholesterol reagent - reference 8D27-02, following a risk of calibration failure and / or a risk of obtaining out of specification checks. This device allows the determination of cholesterol in serum or plasma on the ALCYON automaton.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
ABBOTT DIAGNOSTIC withdraws from the market batches 85124HW00 (per.14.05.03); 89031HW00 (per 13.12.03) and 92010HW00 (per 19.12.03) of the in vitro diagnostic medical device called ALCYON HDL Direct - reference 8D42-02, following a stability problem leading to the failure of the calibration or Obtaining values from out-of-specification controls. This device allows the determination of cholesterol / HDL (high-density lipoprotein) on the ALCYON PLC.
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, 2005, the company BIOCODE HYCEL withdrew from the market lot 016 (per 30/04/2006) of the in vitro diagnostic medical device called Alkaline Phosphatase reference R5A650A following a filling to 50 ml of reagent bottles REAG1 ( buffer) instead of 40 ml. This defect causes an overflow of the liquid during the preparation of the working solution by pouring the REAG 2 (substrate) into the REAG 1 (buffer) vial. This device is a kit used for the quantitative determination of the alkaline phosphatase in the serum or plasma samples. The company has directly notified the recipients of the offending batch by means of the attached message (11/07/2005) (21 KB) validated by Afssaps. This information is intended for those responsible laboratories, the directors of health establishments and the 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
QARAD (manufacturer ATRIA) withdraws from the market batches of the following in vitro diagnostic medical devices:. ATRIA SEQR Allele HLA-A SBT - lot A520H04 (per 13/11/05) ATRIA SEQR Allele HLA-B SBT - lot B517H04 (per 13/11/05 ATRIA Allele SEQR HLA-C SBT - lot C520H04 (per 13 / 11/05 ATRIA SEQR Allele DRB1 SBT - lot R51J04 (per 13/11/05) ATRIA SEQR Allele DQB1 SBT-lot Q59J04 (per 13/11/05 ATRIA Allele SEQR DPB1 SBT- lot P59J04 (per 13/11 / 05), following the demonstration of a decrease in the stability time: the actual expiry dates of the DNA sequencing reaction mixtures contained in these product kits are earlier than those indicated on the product labels. The company has directly notified the recipients of the lots concerned by means of the attached message (26/11/2004) (61 KB) Letter from Atria (26/11/2004) (61 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
On 29/02/08, ALN Implants Chirurgiques has withdrawn lots 0107A - 0207A - 0207B - 0307A - 0407A from references FF.010995 - FJ.120096 - FB.010500 of the medical device called ALN Cell Vein Filters, manufactured by ALN Surgical Implants, following a nonconformity detected at the angle of the strands of attachment of the filter, this angle being greater than the angle validated by the manufacturer. The company ALN Implants Chirurgicaux has directly notified the recipients of the incriminated lots with the message attached (29/02/2008) (20 KB) validated by Afssaps. This information is intended for the directors, 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
On September 1, 2001, Baxter sent a warning message to the physician in charge and / or pharmacist in charge of 9 hemodialysis centers in possession of ALTHANE A-18 dialysis machines, to inform them of the suspension of use and all batches of dialyzers ALTHANE A-18 are recalled. See also the press release of 01/09/0. . Alert message to the physician in charge and / or pharmacist in charge of the center (Copy to the materiovigilance correspondent). September 1, 2001. Subject: ALTHANE A-18 dialysis machine (code 237018. Dear Doctor, Our company has recalled in Spain on August 31, 2001 two batches of ALTHANE A-18 dialyzers, following the deaths of 10 people. recalled, are not marketed in France .. Although there is no evidence of a link between our dialyzers and the death of these patients, this action was initiated as a precautionary measure in the interest of the safety of patients. We have been informed that other possible causes unrelated to dialyzers are being evaluated in the Spanish centers that reported these events. "The analyzes conducted to date on A-18 dialysers revealed no anomaly .. Our traceability allowed us to identify that your center uses this type of ALTHANE A-18 dialyser. At the request of the Afssaps, we proceed to the recall of all ALTHANE A-18 dialyzer batches. in your possession will have to We will be returned as soon as possible. Our services will contact you to organize with you the conditions of recovery of these products. In addition, we ask that you immediately stop using these devices and inform the centers or patients to whom this device has been provided. For any additional information, a telephone number is at your disposal: 01 34 61 53 3. Please accept, Dear Doctor, the assurance of our highest consideration .. Nicole Denjo. Director, Global Vigilance. Baxter, Renal Therapy Division
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 batches 9342298 (per 01.07.01) and 9327298 (per 01.10.01) of the reagent denominated BD BACTEC SIRE reference 442102, of the company BECTON DICKINSON BIOSCIENCES are withdrawn from the market following a mislabeling. A new test is recommended for samples that have been found either resistant to streptomycin and isoniazid, or sensitive to streptomycin and isoniazid.
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 Afssaps was informed on October 6, 2004 by the company Centerpulse of a withdrawal of the market on October 5, 2004 from all lots of the medical device called alumina head diameter 28 mm, 8/10 cone, short neck, reference 15.13.28.05 following a risk of rupture of these heads .. The health institutions concerned by this recall were warned directly using the message attached (03/10/2004) (12 ko) .. This information is for to the directors and local correspondents of materiovigilance for diffusion to the services concerned. The other competent European authorities were not informed of this measure, France being the only country concerned by this recall. Courrier Centerpulse (03/10/2004) (12 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 PRUMENET company, authorized by AMECO MEDICAL INDUSTRIES, is in agreement with Afssaps, withdrawing from the batches market the references of the medical devices of the range AMECATH mentioned in the appendix (13/12/2007) (17 ko) distributed by EUROMEDIS laboratories, packaged in English and containing a notice in English which may not correspond to the device concerned. The products are to be returned to the EUROMEDIS Laboratories for the attention of ZA quality service of the 60290 NEUILLY SOUS CLERMONT. This information is intended for hospital pharmacists, directors and materiovigilance 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
Afssaps has been informed of a recall of Amo Prestige OPO40 tubing packs used with the AMO Prestige phacoemulsification system. This recall was made by the company AMO March 31, 2004 following a problem of sealing of the outer packaging. Health facilities concerned by the recall in France received the enclosed letter (31/03/2004) (38 KB). The other European Competent 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
Bio-Rad withdraws lots 3A1389 from the market (per 30.07.04); 3B1390 (per 15.08.04) and 3B1391 (per 30.08.04) of the in vitro diagnostic medical device called: antibiotic discs: Amoxicillin + Clavulanic acid - reference 66178 (4x50 discs), following the possibility - under certain conditions This device makes it possible to study the sensitivity of a bacterial strain to Amoxicillin + Clavulanic acid.
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
Bio-Rad withdraws from the market batches 2M1387 (per 15.06.04) and 2M1388 (per 30.06.04) of the in vitro diagnostic medical device called: Amoxicillin disks + Clavulanic acid - reference 66178 (4x50 disks) , following a problem of stability of the formulation "Amoxicillin + Clavulanic acid". This device makes it possible to study the sensitivity of a bacterial strain to Amoxicillin + Clavulanic acid.
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 ev3 has withdrawn from the market on 06/06/07 the lot 1650307 of the medical device called kit Amplatz Goose Neck Snare reference GN3000 following the presence in the kit of a catheter 4 French instead of a catheter 6 French. The company has directly notified the recipients of the offending lot with the message attached (06/06/2007) (35 KB) 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 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
Roche Diagnostics withdraws the lots from the market. E13115 (version 31.07.05) of the in vitro diagnostic medical device called Amplicor Detection Internal Control - reference 207 633 06. E13307 (March 30, 2009) of the in vitro diagnostic medical device called Amplicor Mycobacterium tuberculosis detection (MTB) - reference 207 574 62. E11231 (version 30.09.04) of the in vitro diagnostic medical device called Amplicor HIV-1 Monitor v1.5 - reference 211 177 5. following the demonstration of the potential appearance of a blue precipitate during use of the conjugate Peroxidase-Avidin (AV-HRP) / lot E09659 contained in these batches .. The results returned with these lots are considered correct and valid. However, this precipitate can, in rare cases, increase the background noise in the Amplicor MTB device and result in lower positive results; the weakly positive results should be reviewed and reinterpreted according to the clinical data (according to the instructions). These devices use a molecular biology technique (PCR: Polymerase Chain Reaction) for the qualitative or quantitative research of specific nucleic acids. .. Amplicor Detection Internal Control is used with the manual Amplicor MTB Detection Kit for the detection of Mycobacterium tuberculosis. Amplicor HIV-1 Monitor v1.5 is a manual kit for the determination of HIV-1 RNA, used in the treatment of patients infected with HIV-1, known.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
On April 6, 2005, the company ROCHE Diagnostics withdrew from the market lot F09579 of the medical device for in vitro diagnostic called Kit AMPLICOR HPV Amplification reference 3610799190 following. the possibility of obtaining more frequent ß-globin Optical Density results for the positive control, leading to the invalidation of the series. the theoretical possibility that a sample with a very low HPV titre may give a negative result even though the series has been validated by the positive control. This device is used for the detection of high-risk human papillomavirus (HPV) DNA genotypes in clinical specimens (cervical cells taken in liquid medium). The company has directly notified the recipients of the offending lot by means of the message. attached (06/04/2005) (78 ko) 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 and to the correspondents of reactovigilance for diffusion, if necessary, to the services concerned.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
Lots 904312, 905246, 906507, 907441 and 908161 of the reagent called "AMPLIFIED MYCOBACTERIUM TUBERCULOSIS Direct test" (ref: 39006) of the company BIO MERIEUX are withdrawn from the market following a risk of false-negative result by inhibition of the reaction of amplification on some samples.
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
ARGENE BIOSOFT withdraws from the market the batch G2206 (per 06.03) of the in vitro diagnostic medical device called Anti-ADENOVIRUS GROUPE (except ADV-8) / clone BIO-11 / references 11-021 and 14-021, following the detection of a decrease of sensitivity with respect to types 2 and 12 of Adenovirus. This device is used for the detection of Adenoviruses in infected cells obtained from samples of secretions and cells of the respiratory tracts or after isolation on cell cultures ...