Lower risk Medical device recall · FDA · Published July 31, 2024

Beckman Coulter IGM Reagent Recall: Sensitivity Issues in Immunochemistry Tests

Beckman Coulter recalls IGM Immunoglobulin M Reagent REF 447610 due to sensitivity problems in immunochemistry tests. Affected lots M307362 and M309410 may not meet required sensitivity levels.

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

🇺🇸 FDA recall #Z-0118-2025Medical device Beckman Coul: Inc. ›

Lower-risk recall

Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU

Take action

Contact the company

Recalling firmBeckman Coulter Inc.250 S Kraemer Blvd · Brea, CA 92821-6232

✎ GovInfoNow plain-language explainer

Beckman Coulter is recalling IGM Immunoglobulin M Reagent REF 447610 because some batches don't meet the sensitivity standards specified in the user manual. This could lead to inaccurate test results in immunochemistry systems. Read more at govinfonow.com/recall/54375-beckman-coulter-igm-reagent-recall-sensitivity-issues-in-immunochemistry-tests.

Source Summary by GovInfoNow · govinfonow.com/recall/54375-beckman-coulter-igm-reagent-recall-sensitivity-issues-in-immunochemistry-tests · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0118-2025

Cite this page

“Beckman Coulter IGM Reagent Recall: Sensitivity Issues in Immunochemistry Tests.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54375-beckman-coulter-igm-reagent-recall-sensitivity-issues-in-immunochemistry-tests. Based on FDA recall #Z-0118-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0118-2025%22&limit=1).

The FDA announced on July 31, 2024, that Beckman Coulter Inc. is recalling IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 due to sensitivity issues. The agency classified the recall as Class II.

How to tell if you have it

Brand: Beckman Coulter, Inc.
Product: IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent
Catalog Number: 447610
Lot Numbers: M307362, M309410

The hazard

The firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU. The product is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.

Context

GovInfoNow's records show Beckman Coulter, Inc. has 132 other recalls on record since June 20, 2017. Recent similar recalls include the Beckman Coulter DxC 500i Modules with Software 1.5 recall (July 15, 2026), the Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 DVD Kit recall (June 26, 2026), and the Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026). Other recent recalls of similar products include the Beckman Coulter Bicarbonate Reagent May Cause False High Results - Recall (October 14, 2025) and the Immuno-Mycologics Immy Neutralization Buffer Recall (March 26, 2026).

How to tell if you have this one

Check the lot number on the reagent container. Affected lots are M307362 and M309410. The product is sold under catalog number 447610.

Brand
Beckman Coul: Inc.
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Number
Look for lot numbers M307362 or M309410 on the reagent container.

Where it went and when

Where it was distributed

Distributed in 15 states, and outside the U.S.

FDA distribution: “U.S.: AZ, CA, CO, FL, GA, HI, IL, MA, MI, MO, ND, NY, OH, PA, and TX O.U.S.: Australia, Belgium, Brazil, Chile, China, Czechia, Ecuador, France, Germany, Greece, Hong Kong, India, Italy, Kuwait, Mexico, Philippines, Poland, Portugal, Saudi…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Massachusetts, Michigan, Missouri, New York, North Dakota, Ohio, Pennsylvania, Texas.

Recall timeline

FDA published this recall 3 months after the firm started it.

Jul 31, 2024Firm started the recall
Oct 17, 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.

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Link to this recall

<a href="https://govinfonow.com/recall/54375-beckman-coulter-igm-reagent-recall-sensitivity-issues-in-immunochemistry-tests">Beckman Coulter IGM Reagent Recall: Sensitivity Issues in Immunochemistry Tests (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-0118-2025 (July 31, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0118-2025 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.