Recall Z-0100-2024 ยท MSW System, Test, Thyroglobulin
Beckman Coulter, Inc.
Access Thyroglobulin Calibrators
| Date | Oct 11, 2023 (initiated Jul 6, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Other |
| Action | 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 Acce |
| Quantity | 5980 units |
| Distribution | worldwide except US, Canada, and China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031269 | ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS Beckman Coulter, Inc., May 2, 2003 |