Lower riskMedical device recall · FDA · Published April 14, 2021
Beckman Coulter Access SARS-CoV-2 Antigen Test May Give False Negatives
Beckman Coulter recalls Access SARS-CoV-2 Antigen tests that may produce false negative results if stored in certain conditions. Affected units include specific model numbers and lots.
“Beckman Coulter Access SARS-CoV-2 Antigen Test May Give False Negatives.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62787-beckman-coulter-access-sars-cov-2-antigen-test-may-give. Based on FDA recall #Z-1670-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1670-2021%22&limit=1).
Beckman Coulter Inc. recalled Access SARS-CoV-2 Antigen kits due to false negative results when stored in certain conditions, according to the FDA on April 14, 2021.
Specimens collected in transport media may result in false negative results when stored in certain conditions.
Context
GovInfoNow's records show Beckman Coulter, Inc. has 133 other recalls on record since 2017-06-20. Other recent recalls of similar products include Meridian Bioscience Revogene C. difficile Test Recall (2025-12-05) and Hologic Aptima HPV Assay Kit Recall (2026-02-18).
How to tell if you have this one
Check for the model numbers: 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, and R1e. The recall includes all lots with the unique identifier (01)15099590742713.
Verify the model numbers and lot identifiers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 31 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of Alabama, Arizona, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, West Virginia.
Recall timeline
FDA terminated this recall 2.1 years 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-1670-2021 (April 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1670-2021 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.