Events

Rappel de Device Recall Access Free T4 Assay

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 Beckman Coulter Inc..

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
    55196
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2658-2010
  • Date de mise en oeuvre de l'événement
    2010-03-24
  • Date de publication de l'événement
    2010-10-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90279
  • 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
    Radioimmunoassay, Free Thyroxine - Product Code CEC
  • Cause
    The recall was initiated after beckman coulter determined that kit boxes for access free t4 reagent (ref 33880), lot number 916293 may contain reagent packs labeled as access vitamin b12, (ref 33000), lot 916277. using an access vitamin b12 reagent pack, lot 916277, filled with access free t4 reagents may generate incorrect patient results.
  • Action
    A Product Corrective Action (PCA) letter was sent on March 24, 2010 to the affected customers. The letter provides the customers with an explanation of the problem identified and instructs them to discard the FT4 kit, Lot 916293 in their stock if the FT4 packs within the kit packaging are labeled as Vitamin B12 Lot 916277. The PCA requested customers: (1) Inspect all Access Vitamin B12 reagent packs that have been removed from their kit boxes, including reagent packs currently loaded on your system and discard any reagent packs labeled as Access Vitamin B12, lot 916277; (2) Inspect your Access Free T4 reagent kit inventory for any reagent packs labeled as Access Vitamin B12, lot 916277 and discard any reagent packs labeled as Access Vitamin B12, lot 916277; (3) Review your historical quality control to ensure that assay performance for Access Vitamin B12 lot 916277 has been within your laboratory specifications. In addition customers were instructed to share this information with their laboratory staff and retain this notification as part of your laboratory Quality System documentation. Complete and return the enclosed response form within 10 days so Beckman Coulter can be assured that you have received this important notification. If customers need assistance or have any questions regarding the notification, they were instructed to contact Customer Technical Support Center at 1-800-854-3633 in the United States and Canada.

Device

Device Recall Access Free T4 Assay

Manufacturer

Beckman Coulter Inc.
  • Adresse du fabricant
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA