Beckman Coulter recalls Access Thyroglobulin Antibody II (TgAb) assays with incorrect instructions that may cause false-low results. Affected units shipped from July 2021 to current. Contact for remedy.
“Beckman Coulter Access Thyroglobulin Antibody II: False-Low Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54046-beckman-coulter-access-thyroglobulin-antibody-ii-false-low-results-risk. Based on FDA recall #Z-0265-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0265-2025%22&limit=1).
The FDA announced on Sept. 5, 2024, that Beckman Coulter is recalling Access Thyroglobulin Antibody II kits because their Instructions for Use incorrectly state biotin interference was remediated, potentially causing false-low results. The agency issued recall number Z-0265-2025.
How to tell if you have it
Brand: Beckman Coulter
Product: Access Thyroglobulin Antibody II, REF A32898
IFU Part Numbers: B14994, B63978, and A38168
UDI-DI: 15099590202910
Distribution: Nationwide to the U.S. (including Puerto Rico) and Mexico; government distribution included
The hazard
The Instructions for Use for the device incorrectly state that biotin interference has been remediated. This error could result in potentially false-low test results.
Context
GovInfoNow's records show Beckman Coulter, Inc. has had 132 other recalls on record since June 20, 2017. Recent similar recalls include the Beckman Coulter DxC 500i Modules recall (July 15, 2026) and the Beckman Coulter MicroScan LabPro V5.03 Panel Update recall (June 26, 2026). Other recent recalls of similar products include the Beckman Coulter Bicarbonate Reagent recall (Oct. 14, 2025), the Roche Elecsys Anti-TSHR Assay recall (Nov. 21, 2025), and the Vivoo Protein Test recall (Nov. 22, 2025).
How to tell if you have this one
Check for the product name 'Access Thyroglobulin Antibody II' with reference number A32898. The instructions for use (IFU) part numbers B14994, B63978, and A38168 apply to all units shipped from July 2021 to current.
Brand
Beckman Coulter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the product name and reference numbers to confirm if your unit is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0265-2025 (September 5, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0265-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.