FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0265-2025
- Recalling firm
- Beckman Coulter, Inc.
- 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.
- Status
- Open, Classified
- Initiated
- 2024-09-05
- Posted
- 2024-10-30
- Terminated
- not on file
- 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 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.
- 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.
- Lot, serial or model codes
- All IFU Part Numbers B14994, B63978, and A38168 affect all product/lots shipped from Jul-2021 to current; UDI-DI 15099590202910.
- 510(k) numbers
- ["K112933"]
- PMA numbers
- not on file
- Product code
- JNL
- Firm FEI
- 2122870
- Firm city
- Chaska
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28