Beckman Coulter ACCESS SARS-CoV-2 IgG QC Card Label Error Recall

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

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✎ GovInfoNow plain-language explainer

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.

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

Based on the official FDA remedy

What to do — step by step

Check Card Label
Verify the catalog number is C58964 and the UDI code is 15099590738662.

✎ GovInfoNow

Questions people ask

Why is this card being recalled?

The QC card has a label error for standard deviation values at one level, which could lead to inaccurate test results.

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.

Is this card safe to use?

The card is safe to use if the label error is corrected, but the recall indicates a potential for inaccurate test results.

Take action

Contact Beckman Coulter

We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0875-2021 — Beckman Coulter Beckman Coulter

Hello,

I own a Beckman Coulter that is covered by recall Z-0875-2021 from Beckman Coulter.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

Beckman Coulter Inc. recalls ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems

Lower-risk recall