Use caution Medical device recall · FDA · Published March 16, 2026

Beckman Coulter Access Total T4 Calibrator Recall: False Low Results Risk Incorrect

Beckman Coulter recalls Access Total T4 Calibrator (Catalog No. 33805) with negative bias causing false low patient results. This may lead to unnecessary tests, delayed hyperthyroidism treatment, or incorrect dosing for pregnant patients.

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

🇺🇸 FDA recall #Z-1922-2026Medical device Beckman Coulter ›

Use caution until it’s fixed

Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.

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 Access Total T4 Calibrator models with Catalog No. 33805 due to a negative bias that can cause false low patient results. This risk may lead to unnecessary diagnostic tests, delayed treatment for hyperthyroidism, or incorrect medication dosing for pregnant patients. Read more at govinfonow.com/recall/49718-beckman-coulter-access-total-t4-calibrator-recall-false-low-results.

Source Summary by GovInfoNow · govinfonow.com/recall/49718-beckman-coulter-access-total-t4-calibrator-recall-false-low-results · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1922-2026

Cite this page

“Beckman Coulter Access Total T4 Calibrator Recall: False Low Results Risk Incorrect.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49718-beckman-coulter-access-total-t4-calibrator-recall-false-low-results. Based on FDA recall #Z-1922-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1922-2026%22&limit=1).

The Food and Drug Administration announced on March 16, 2026, that Beckman Coulter, Inc. is recalling Access Total T4 Calibrator, Catalog No. 33805. The device exhibits a negative bias that could cause false low patient results.

How to tell if you have it

Brand: Beckman Coulter
Product: Access Total T4 Calibrator
Catalog No.: 33805
Lots: 538729, 538815, 538898, 539107, 539243
UDI-DI: 15099590225872

The hazard

According to the FDA, Access Total T4 Calibrator lots exhibit a negative bias on DxI 600/800 instruments with slopes outside product specifications. A false low patient result could cause unnecessary additional diagnostic testing or delayed treatment for hyperthyroidism. Incorrect treatment or dose may be used for pregnant patients being monitored for thyroid hormone supplementation.

Context

GovInfoNow's records show Beckman Coulter, Inc. has had 132 other recalls since June 20, 2017. Recent Beckman Coulter recalls include the DxC 500 AU Modules with Software 1.5 (July 15, 2026) and MicroScan LabPro V5.03 Panel Update 11 (June 26, 2026). Other recent recalls of similar products include the Beckman Coulter Emit 2000 Quinidine Assay Recall (July 13, 2026), Roche Elecsys Anti-TSHR Assay Recall (Nov. 21, 2025), and Fujirebio Lumipulse G Amyloid 1-42 Plasma Calibrators Recall (Dec. 11, 2025).

How to tell if you have this one

Check for the calibrator model with Catalog No. 33805. The affected lots are 538729, 538815, 538898, 539107, and 539243. This product was sold with UDI-DI 15099590225872.

Brand
Beckman Coulter
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Calibrator Model
Identify the model number and lot numbers to confirm if your calibrator is affected.

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 Argentina, Austria, Bangladesh, Bolivia (Plurinational State of), Bosnia and Herzegovina, Brazil, Canada, China, C¿te d'Ivoire, Croatia, Czechia, Denmark, Egypt, El Salvador,…” 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 44 days after the firm started it.

Mar 16, 2026Firm started the recall
Apr 22, 2026FDA classified it Class II
Apr 29, 2026Published 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/49718-beckman-coulter-access-total-t4-calibrator-recall-false-low-results">Beckman Coulter Access Total T4 Calibrator Recall: False Low Results Risk Incorrect (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-1922-2026 (March 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1922-2026 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.