Beckman Coulter recalls Access SARS-CoV-2 IgG (1st IS) Assay reagents due to insufficient evidence for Emergency Use Authorization. Affected units include specific lot numbers and UDI codes.
Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute
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📍Recalling firmBeckman Coulter Inc.250 S Kraemer Blvd · Brea, CA 92821-6232
✎ GovInfoNow plain-language explainer
Beckman Coulter is recalling Access SARS-CoV-2 IgG (1st IS) Assay reagents because the emergency use authorization process did not provide enough evidence to approve them for distribution. This recall affects specific lot numbers and UDI codes of the reagents. Read more at govinfonow.com/recall/62077-beckman-coulter-access-sars-cov-2-igg-assay-recall-eua.
“Beckman Coulter Access SARS-CoV-2 IgG Assay Recall: EUA Authorization Insufficient.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62077-beckman-coulter-access-sars-cov-2-igg-assay-recall-eua. Based on FDA recall #Z-2508-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2508-2021%22&limit=1).
The FDA announced on August 5, 2021, that Beckman Coulter Inc. voluntarily recalled Access SARS CoV-2 IgG (1st IS) Assay reagent packs and related calibrators because the firm's Emergency Use Authorization submission contained insufficient evidence for approval. The recall affects kits distributed nationwide in the U.S. and overseas.
Product: Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341
UPC: 15099590746919
UPC: 15099590746926
UPC: 15099590746933
The hazard
The recall was initiated because the firm's submission for Emergency Use Authorization contained insufficient evidence to be granted EUA Authorization to distribute the devices. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Beckman Coulter, Inc. has 133 other recalls on record since June 20, 2017. Recent similar recalls include DxC 500 AU Clinical Chemistry Analyzers (September 2, 2026), DxC 500i Modules with Software 1.5 Risk (July 15, 2026), and MicroScan LabPro V5.03 Panel Update 11 (June 26, 2026). Other recent recalls of similar products include Emit 2000 Quinidine Assay Recall (July 13, 2026), GET TESTED H. pylori Test Recall (November 3, 2025), and GET TESTED Food Allergy Panel Test (IgE) Recall (November 3, 2025).
How to tell if you have this one
Check for the part numbers C74339, C74340, or C74341 and specific lot numbers (124466, 124467, 124468, 124758, 124708) on the reagent packaging. The UDI codes are also listed in the recall notice.
Identify the part numbers and lot numbers on the reagent packaging to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 16 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide distribution in the states of AZ, CA, GA, IL, IA, KY, MI, NJ, NY, NC, OH, PA, Puerto Rico, TN, TX, VA, and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Georgia, Illinois, Iowa, Kentucky, Michigan, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Washington.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-2508-2021 (August 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2508-2021 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.