—#210145

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.

FDA product code: JNL — Immunochemical, Thyroglobulin Autoantibody
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K112933
Affected lot / code info: All IFU Part Numbers B14994, B63978, and A38168 affect all product/lots shipped from Jul-2021 to current; UDI-DI 15099590202910.

Why it was recalled

IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.

Root cause (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 1000 Lake Hazeltine Dr, Chaska, Minnesota 55318-1037

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-09-05
Posted by FDA: 2024-10-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210145. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.