BioMerieux VIDAS FSH Test Recall: Invalid Calibration Risk

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Recalling firmBioMerieux SAChemin De L'Orme · Marcy L'Etoile, N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

BioMerieux's VIDAS FSH test (Ref 30407-01) is recalled because it may give invalid results when using a low calibrator S1. This could lead to incorrect diagnoses of pituitary or gonadal disorders.

Why it’s dangerous

The test may produce invalid calibration results when the low calibrator S1 is used. This could cause incorrect hormone levels to be reported, potentially leading to wrong diagnoses of pituitary or gonadal disorders.

Who’s affected

Healthcare providers using the VIDAS FSH test for hormone diagnosis in the U.S. are most at risk if they rely on inaccurate results.

How to tell if you have this one

Check for the VIDAS FSH test (Ref 30407-01) with lot number 1005888210 distributed in the U.S. The label shows 'bioMerieux SA, France' as the manufacturer.

Brand
BioMerieux
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Test Lot Number
Look for the lot number 1005888210 on the test label to confirm if it's affected.

✎ GovInfoNow

Questions people ask

Is this test used for home testing?

No, this test is for use in clinical labs as part of a diagnostic process, not for home use.

What does 'invalid calibration' mean for test results?

It means the test may give incorrect hormone levels, potentially leading to wrong diagnoses of pituitary or gonadal disorders.

How can I get a replacement if I have the affected test?

The recall record does not specify a remedy or replacement process.

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-2331-2018 — BioMerieux BioMerieux

Hello,

I own a BioMerieux that is covered by recall Z-2331-2018 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-2331-2018 (April 9, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2331-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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 SA recalls VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of

Lower-risk recall