Beckman Coulter ACCESS SARS-CoV-2 IgG QC Card Label Error Recall
Beckman Coulter recalls ACCESS SARS-CoV-2 IgG QC cards with label errors for standard deviation values. This may affect test accuracy in some lab settings.
Lower-risk recall
The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
Contact the company
What happened, in plain English
Beckman Coulter is recalling a specific quality control card for SARS-CoV-2 IgG tests due to a label error that could lead to incorrect standard deviation values. This might cause inaccurate test results if used in the Access Family of Immunoassay Systems. Read more at govinfonow.com/recall/63589-beckman-coulter-access-sars-cov-2-igg-qc-card-label.
Source Summary by GovInfoNow · govinfonow.com/recall/63589-beckman-coulter-access-sars-cov-2-igg-qc-card-label · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0875-2021
Cite this page
“Beckman Coulter ACCESS SARS-CoV-2 IgG QC Card Label Error Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63589-beckman-coulter-access-sars-cov-2-igg-qc-card-label. Based on FDA recall #Z-0875-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0875-2021%22&limit=1).
Why it’s dangerous
The QC card has a label error for standard deviation (SD) values at one level. This could lead to incorrect test results if the card is used in the Access Family of Immunoassay Systems, potentially affecting the accuracy of SARS-CoV-2 IgG tests.
Who’s affected
Lab users who purchased the ACCESS SARS-CoV-2 IgG QC card with catalog number C58964 are likely affected. Those using this card in the Access Family of Immunoassay Systems may be at risk of inaccurate test results.
How to tell if you have this one
Check for the catalog number C58964 on the card. The product is sold with UDI code 15099590738662 and lot number 922407. It is intended for use only on the Access Family of Immunoassay Systems.
- Brand
Beckman Coulter- Category
Medical device
What to do — step by step
Check Card Label
Verify the catalog number is C58964 and the UDI code is 15099590738662.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 27 states.
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, FL, GA, IA, ID, IL, IN, KS,KY, LA, MD, MI, MN, MO, NC, ND, NY, OH, OK, OR, PA, Puerto Rico, SD, TX, WA, and WV. The countries of Andorra, Belgium,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Texas, Washington, West Virginia.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have this card?
Check the catalog number and UDI code to confirm it's the recalled item. No specific action is required beyond verifying the label.
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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-0875-2021 (December 30, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0875-2021 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.