Events

Recall of Device Recall Access Free T4 Assay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beckman Coulter Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55196
  • Event Risk Class
    Class 2
  • Event Number
    Z-2658-2010
  • Event Initiated Date
    2010-03-24
  • Event Date Posted
    2010-10-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90279
  • Notes / Alerts
    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.
  • Extra notes in the data
    Radioimmunoassay, Free Thyroxine - Product Code CEC
  • Reason
    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.
  • Manufacturer Address
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA