Z-0265-2025Class II

Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and...

Name: Z-0265-2025 Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and...
Creator: Beckman Coulter, Inc.
Published: 2024-09-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-09-05 / Open, Classified / root cause: labeling and UDI

FDA source

Beckman Coulter, Inc. began a recall of Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb)... on 2024-09-05. FDA classified it as Class II and gives the reason as "IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0265-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-05
Posted: 2024-10-30
Recalling firm: Siemens Healthcare Diagnostics 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.
Product code: JNL Immunochemical, Thyroglobulin Autoantibody
Reason for recall: IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: All IFU Part Numbers B14994, B63978, and A38168 affect all product/lots shipped from Jul-2021 to current; UDI-DI 15099590202910.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0265-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0265-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-30

Product code JNL

K112933Class IIAccess Thyroglobulin AnitbodyBeckman Coulter, Inc. / cleared 2011-12-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)