bioMerieux VIDAS PCT Test Recall: Substrate Error Causes Delayed Results

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Recalling firmbioMerieux, Inc.100 Rodolphe St · Durham, NC 27712-9402

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✎ GovInfoNow plain-language explainer

What happened, in plain English

bioMerieux is recalling certain VIDAS B.R.A.H.M.S. PROCALCITONIN PCT tests because a substrate error prevents the test from running, leading to potential delayed results. This affects users who need accurate test results quickly.

Why it’s dangerous

The substrate error prevents the test from running correctly, requiring users to run another test. This can lead to delayed results, which may impact timely medical decisions.

Who’s affected

Users of the recalled VIDAS B.R.A.H.M.S. PROCALCITONIN PCT tests with specific lot numbers are affected. Healthcare providers and labs using these tests for medical diagnostics are most at risk.

How to tell if you have this one

Check the lot numbers: 1008603580, 1008748010, 1008888030, 1008584190, 1008647850. The product is labeled as VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01.

Brand
bioMerieux
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Verify your test lot numbers against the list: 1008603580, 1008748010, 1008888030, 1008584190, 1008647850.

✎ GovInfoNow

Questions people ask

Why is this test being recalled?

bioMerieux has received complaints about a substrate error that prevents the test from running, leading to potential delayed results.

What should I do if I have the recalled test?

Check your lot numbers against the list provided. If affected, contact bioMerieux for further instructions.

Is there a fix for this issue?

The recall record does not specify a remedy.

Take action

Contact bioMerieux

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

✉️ Open in email

Subject: Recall Z-0428-2022 — bioMerieux bioMerieux

Hello,

I own a bioMerieux that is covered by recall Z-0428-2022 from bioMerieux.

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-0428-2022 (September 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0428-2022 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.

bioMerieux, Inc. recalls VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01

Lower-risk recall