Lower risk Medical device recall · FDA · Published February 8, 2024

Beckman Coulter Access Total T4 Reagent May Give Erroneous Thyroid Results

Beckman Coulter recalls four lots of Access Total T4 reagent (lots 338555-338958) due to possible imprecision causing inaccurate thyroid test results. Affected units expire by October 2024.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1303-2024Medical device Beckman Coulter ›

Lower-risk recall

Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.

Take action

Contact the company

Recalling firmBeckman Coulter, Inc.1000 Lake Hazeltine Dr · Chaska, MN 55318-1037

✎ GovInfoNow plain-language explainer

Beckman Coulter is recalling four specific lots of Access Total T4 reagent for thyroid tests because they may produce inaccurate results. This could lead to incorrect thyroid assessments if used in medical testing. Read more at govinfonow.com/recall/56176-beckman-coulter-access-total-t4-reagent-may-give-erroneous-thyroid.

Source Summary by GovInfoNow · govinfonow.com/recall/56176-beckman-coulter-access-total-t4-reagent-may-give-erroneous-thyroid · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1303-2024

Cite this page

“Beckman Coulter Access Total T4 Reagent May Give Erroneous Thyroid Results.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56176-beckman-coulter-access-total-t4-reagent-may-give-erroneous-thyroid. Based on FDA recall #Z-1303-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1303-2024%22&limit=1).

The FDA announced on Feb. 8, 2024, that Beckman Coulter, Inc. is recalling Access Total T4 thyroxine reagent assays due to imprecision that may cause erroneous results. The agency issued the Class II recall for four specific lots distributed worldwide.

How to tell if you have it

Brand: Beckman Coulter
Product: Access Total T4, REF 33800, IVD, thyroxine reagent assay
Lot numbers: 338555 (exp. 31 JUL 2024), 338556 (exp. 31 AUG 2024), 338734 (exp. 30 SEP 2024), and 338958 (exp. 31 OCT 2024)
UDI-DI: 15099590225742
Quantity: 64,009 kits

The hazard

Four lots of Access Total T4 reagent demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Beckman Coulter, Inc. has 132 other recalls on record since June 20, 2017. Other recent recalls of similar products include Beckman Coulter DxC 500i Modules with Software 1.5 (July 15, 2026), Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 (June 26, 2026), and Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026). Other recent recalls of similar products include Beckman Coulter Bicarbonate Reagent (Oct. 14, 2025), Roche Elecsys Anti-TSHR Assay (Nov. 21, 2025), and Beckman Coulter LDL Cholesterol Reagent (Dec. 8, 2025).

How to tell if you have this one

Check the lot numbers: 338555 (expires July 2024), 338556 (August 2024), 338734 (September 2024), or 338958 (October 2024). The product is used for thyroid tests and expires by October 2024.

Brand
Beckman Coulter
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Look for lot numbers 338555, 338556, 338734, or 338958 on the reagent packaging.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Bahrain, Bangladesh, Bolivia, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Egypt, El Salvador, Georgia, Greece, Hong Kong, India, Kazakhstan,…” 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 48 days after the firm started it.

Feb 8, 2024Firm started the recall
Mar 15, 2024FDA classified it Class II
Mar 27, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/56176-beckman-coulter-access-total-t4-reagent-may-give-erroneous-thyroid">Beckman Coulter Access Total T4 Reagent May Give Erroneous Thyroid Results (GovInfoNow)</a>

Where this comes from

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-1303-2024 (February 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1303-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.