Access Thyroglobulin Antibody (Beckman) – Result Accuracy Issue (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Beckman Coulter, Inc.
Lot Codes / Batch Numbers
All IFU Part Numbers B14994, B63978, and A38168 affect all product/lots shipped from Jul-2021 to current, UDI-DI 15099590202910.
Products Sold
All IFU Part Numbers B14994, B63978, and A38168 affect all product/lots shipped from Jul-2021 to current; UDI-DI 15099590202910.
Beckman Coulter, Inc. is recalling Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B6397 due to IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.
Recommended Action
Per FDA guidance
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 the consignee that Beckman Coulter will update the IFUs to contain accurate biotin interference claims for the assay. Notifications will be sent when the updated IFU is available for download from the Beckman Coulter website. The letter also reports that IFU part number A38168 has been retired and will not be updated. If the affected product has been forwarded to another laboratory, the consignee is requested to provide them a copy of the letter. The consignee is to respond within 10 days electronically via email or manually by completing and returning the enclosed response form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026