Recall Z-0265-2025 ยท JNL Immunochemical, Thyroglobulin Autoantibody
Beckman Coulter, Inc.
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.
| Date | Oct 30, 2024 (initiated Sep 5, 2024) |
| Status | Open, Classified |
| Reason | IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results. |
| Root cause | Error in labeling |
| Action | The recalling firm issued letters dated August 28, 2024, which were issued 9/5/2024 via email and first class mail. The letter describes the issue, impact, and actions that should be taken. The consignee is to retain a copy of the letter as it serves as current labeling regarding biotin interference with the Access Thyroglobulin Antibody II assay. Appendix A of the letter provides the incorrect and correct sections of the IFUs. The recalling firm recommends sharing the content of the letter with their laboratory and/or medical director to assess the need for retesting. The letter informs |
| Quantity | 465,481 kits |
| Distribution | Distribution was made nationwide to the U.S., including Puerto Rico. There was government distribution but no military distribution. Foreign distribution was made to Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112933 | ACCESS THYROGLOBULIN ANITBODY Beckman Coulter, Inc., Dec 27, 2011 |