Lower risk Medical device recall · FDA · Published August 28, 2024

Beckman Coulter Access TSH Reagent Packs May Give Low TSH Results

Beckman Coulter recalls specific lots of Access TSH reagent packs that may produce erroneously low thyroid-stimulating hormone results. Affected lots include 339117, 338724, 439341, 338367, 338057, 234251.

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

🇺🇸 FDA recall #Z-0094-2025Medical device Beckman Coulter ›

Lower-risk recall

Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) 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 certain lots of Access TSH reagent packs that may produce falsely low thyroid-stimulating hormone (TSH) results. This could lead to incorrect diagnoses of thyroid or pituitary disorders if used in medical testing. Read more at govinfonow.com/recall/54159-beckman-coulter-access-tsh-reagent-packs-may-give-low-tsh.

Source Summary by GovInfoNow · govinfonow.com/recall/54159-beckman-coulter-access-tsh-reagent-packs-may-give-low-tsh · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0094-2025

Cite this page

“Beckman Coulter Access TSH Reagent Packs May Give Low TSH Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54159-beckman-coulter-access-tsh-reagent-packs-may-give-low-tsh. Based on FDA recall #Z-0094-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0094-2025%22&limit=1).

Beckman Coulter, Inc. voluntarily recalled The Access TSH (3rd IS) assay reagent packs on Aug. 28, 2024, according to the FDA. Certain lots may produce erroneously low thyroid-stimulating hormone results.

How to tell if you have it

Brand: Beckman Coulter
Product: The Access TSH (3rd IS) assay reagent packs
Lot Numbers: 339117, 338724, 439341, 338367, 338057, 234251
Units affected: 2805

The hazard

Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.

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).

How to tell if you have this one

Check the lot numbers on the reagent packs: 339117, 338724, 439341, 338367, 338057, or 234251. The Access TSH (3rd IS) assay is used with the DxI 9000 Access Immunoassay Analyzer.

Brand
Beckman Coulter
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Verify the lot number on the reagent pack to see if it is one of the affected lots: 339117, 338724, 439341, 338367, 338057, or 234251.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Croatia, France, Germany, Ireland, Italy, Slovakia, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland.” 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 56 days after the firm started it.

Aug 28, 2024Firm started the recall
Oct 16, 2024FDA classified it Class II
Oct 23, 2024Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using the reagent packs immediately?

No, the recall does not require immediate discontinuation. Affected lots can be identified and checked for use.

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Link to this recall

<a href="https://govinfonow.com/recall/54159-beckman-coulter-access-tsh-reagent-packs-may-give-low-tsh">Beckman Coulter Access TSH Reagent Packs May Give Low TSH 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-0094-2025 (August 28, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0094-2025 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.