Beckman Coulter Access SARS-CoV-2 Antigen Test May Give False Negatives

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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 its Access SARS-CoV-2 Antigen tests because specimens stored in certain conditions may give false negative results. This could lead to incorrect test outcomes and missed infections.

Why it’s dangerous

The test may produce false negative results if specimens are stored in certain conditions, such as improper temperature or humidity. This could lead to incorrect test outcomes and missed infections.

Who’s affected

Healthcare workers and labs using the Access SARS-CoV-2 Antigen tests are most at risk. The recall affects specific model numbers and lots sold globally.

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.

Brand
Beckman Coulter
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the model numbers and lot identifiers listed in the recall notice.

✎ GovInfoNow

Questions people ask

Why is this test being recalled?

The test may produce false negative results if specimens are stored in certain conditions, such as improper temperature or humidity.

What model numbers are affected?

The affected model numbers are 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, and R1e.

How can I check if my test is affected?

Check the product label for the model numbers and unique identifier (01)15099590742713.

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-1670-2021 — Beckman Coulter Beckman Coulter

Hello,

I own a Beckman Coulter that is covered by recall Z-1670-2021 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-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.

Beckman Coulter Inc. recalls Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d,

Lower-risk recall