Beckman Coulter, Inc. Access Thyroglobulin Calibrators Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11% in patient results.

Recommended Action

Per FDA guidance

Beckman Coulter issued an Urgent Medical Device Recall letter dated 06/28/2023 to its consignees affected worldwide on 07/06/2023 via email or letter and followed with an updated letter (dated 07/07/2023) issued on 07/14/2023 which contained FDA suggested edits. The notice explained the problem, the risk to the patient and requested the following actions be taken: If you have downloaded the alternative calibrator card issued in April 2023, please discard that calibrator card, and do not use it moving forward. . Only use Access Thyroglobulin calibrator lots 338013 or higher to calibrate Access Thyg reagent packs (C71762), when this becomes available in your laboratory. . Continue to use any lot of Thyroglobulin Calibrator (PN 33865) with Access Thyroglobulin Reagent packs (33860). The firm issued an Important Product Notification letter was issued on 2023 August 10 notifying customers in the US, Canada, and China that they were NOT affect by this issue and to disregard the prior Urgent Medical Device Recall letters.