Beckman Coulter recalls ACCESS SARS-CoV-2 Antigen QC (REF: C68670) due to potential false positive results. This may lead to incorrect COVID-19 diagnoses. Affected units include all lots.
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
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📍Recalling firmBeckman Coulter Inc.250 S Kraemer Blvd · Brea, CA 92821-6232
✎ GovInfoNow plain-language explainer
Beckman Coulter is recalling its ACCESS SARS-CoV-2 Antigen QC test kits because they might give false positive results, which could lead to incorrect COVID-19 diagnoses. This recall affects all units sold and is important for accurate testing. Read more at govinfonow.com/recall/62247-beckman-coulter-access-sars-cov-2-antigen-qc-recall-false.
“Beckman Coulter ACCESS SARS-CoV-2 Antigen QC Recall: False Positive Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62247-beckman-coulter-access-sars-cov-2-antigen-qc-recall-false. Based on FDA recall #Z-2257-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2257-2021%22&limit=1).
The FDA announced on July 1, 2021, that Beckman Coulter Inc. is recalling ACCESS SARS-CoV-2 ANTIGEN QC because the test may generate false positive results. The agency said this could result in an incorrect diagnosis.
Contents: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD
UPC: 15099590742737
Lots: All Lots
The hazard
The FDA said the ACCESS SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis.
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 DxC 500i Clinical Analyzer Modules May Show Incorrect Test Results Due to Software Issue (2026-09-02), Beckman Coulter DxC 500 AU Modules with Software 1.5 Risk Patient Test Errors (2026-07-15), and Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 DVD Kit: Incorrect Algorithms May Affect Test Results (2026-06-26).
How to tell if you have this one
Check for the product name 'ACCESS SARS-CoV-2 ANTIGEN QC' with reference number C68670. All lots of this product are affected.
Brand
Beckman Coulter
Product
Beckman Coulter Inc. recalls ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide Distribution in the states of Alabama Alaska 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, Wisconsin OUS: New Zealand, Libya
Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;; All Lots
451 units
Z-2257-2021
ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;; All Lots
544 units
Z-2258-2021
ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017; All Lots
3,672 unitsin total
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the product name and reference number C68670 to confirm if your kit is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 33 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution in the states of Alabama Alaska Arizona Arkansas California Connecticut Delaware Florida Georgia Idaho Illinois Indiana Iowa Kentucky Louisiana Maine Maryland Massachusetts Michigan Mississippi New Hampshire New…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, 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, Wisconsin.
Recall timeline
FDA terminated this recall 23 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-2257-2021 (July 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2257-2021 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.