Events

Rappel de Device Recall Kallestad (TM) HEp2

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Bio-Rad Laboratories.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    49083
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2428-2008
  • Date de mise en oeuvre de l'événement
    2008-07-29
  • Date de publication de l'événement
    2008-09-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-03-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72723
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Antimitochondrial Antibody - Product Code DBM
  • Cause
    The homogeneous positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the qc report label included with each test kit.
  • Action
    On 7/25/08, the firm began to notify their customers about the recall via an Urgent Product Correction sent by DHL or FEDEX. Included with the customer letter was a revised QC Card. International subsidiaries were notified by e-mail with the customer letter and revised QC Card attached. The letter informed customers of the recall and directing them to the revised QC card which was attached to the letter. The instructions are to, "Please use this to replace the card in any kits remaining in your facility." If customers have any questions or require additional QC cards, they are to contact Technical Support.

Device

Device Recall Kallestad (TM) HEp2
  • Modèle / numéro de série
    Lot # and exp: For catalog # 30471: 951567, exp 2/28/09; 954479, exp 12/31/08; 954566, exp 11/30/08; 954895, exp 3/31/09; 955422, exp 2/28/09; 955495, exp 2/28/09; for catalog # 30472: 951564, exp 2/28/09; 954135, exp 2/28/09; 954481, exp 3/31/09; 954567, exp 3/31/09; 954858, exp 3/31/09; 954927, exp 3/31/09; 955197, exp 4/30/09; and for catalog # 32583: 951566, exp 2/28/09.
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of AUSTRALIA, BRAZIL, CANADA, CHINA , FRANCE, GERMANY, HONG KONG, INDIA, ITALY, JAPAN, MEXICO, NEW ZEALAND, POLAND, SINGAPORE, SOUTH KOREA , TAIWAN, UNITED KINGDOM, and URUGUAY.
  • Description du dispositif
    Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled "BIO-RAD Kallestad (TM) HEp-2 Cell Line Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA 98052... FRANCE, Bio-Rad Laboratories, 92430 Marnes La Coquette". Catalog #: 30471 - 12 well kit, 60 tests; 30472 - 12 well kit, 240 tests; and 32583 - 6 well kit, 48 tests.
  • Manufacturer
    Bio-Rad Laboratories

Manufacturer

Bio-Rad Laboratories
  • Adresse du fabricant
    Bio-Rad Laboratories, 6565 185th Ave NE, Redmond WA 98052-5039
  • Société-mère du fabricant (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA