Events

Recall of Device Recall Beckman Coulter Access Free T3 Calibrator

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
    55952
  • Event Risk Class
    Class 2
  • Event Number
    Z-2178-2011
  • Event Initiated Date
    2009-12-17
  • Event Date Posted
    2011-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92314
  • 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
    in vitro diagnostic - Product Code JIT
  • Reason
    Beckman coulter has confirmed reports that the access free t3 calibrator lot numbers 989902, 989903, 989904, 989905, 989906 and 989907 will show a decline in performance before reaching their stated expiration date. the affected calibrator lots will cause one or more quality control samples to produce out-of-range high result.
  • Action
    Beckman Coulter sent a letter dated December 29, 2009, providing the customers with an explanation of the reason for recall and asked them to take the following actions: - Discontinue use of the lots of reagent listed above. - Review your historical quality control to ensure that the assay performance of these lots has been within your laboratory specifications. NOTE: Out-of-range high quality control results may indicate invalid test results. Consignees were asked to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation; and complete and return the enclosed response form within 10 days so that Beckman can be assured that they received this important notification. Assistance or questions regarding this notification, were directed to Technical Support at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact consignees were told to contact their local Beckman Coulter Representative.

Device

Device Recall Beckman Coulter Access Free T3 Calibrator
  • Model / Serial
    Lot #'s: 989902, 989903, 989904, 989905, 989906 & 989907
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution Nationwide and Canada.
  • Product Description
    Beckman Coulter Access Free T3 Calibrators, Part Number A13430 in vitro diagnostic.
  • Manufacturer
    Beckman Coulter Inc.

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