Lower riskMedical device recall · FDA · Published April 9, 2018
BioMerieux VIDAS FSH Test Recall: Invalid Calibration Risk
BioMerie: VIDAS FSH test (Ref 30407-01) recalled due to potential invalid calibration with low calibrator S1. Affected units distributed in the U.S. with lot #1005888210.
“BioMerieux VIDAS FSH Test Recall: Invalid Calibration Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71487-biomerieux-vidas-fsh-test-recall-invalid-calibration-risk. Based on FDA recall #Z-2331-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2331-2018%22&limit=1).
The FDA announced on April 9, 2018, that BioMerieux SA voluntarily recalled VIDAS FSH (Ref 30407-01) due to the hazard of invalid calibration with low calibrator S1. The agency classified the recall as Class II.
How to tell if you have it
Brand: BioMerieux
Product: VIDAS FSH, Ref 30407-01, IVD, Rx
Lot code: #1005888210
Quantity: 59 units
The hazard
The recall addresses the hazard of invalid calibration with low calibrator S1 while using the product. The VIDAS FSH is an automated quantitative enzyme-linked fluorescent immunoassay for determining human follicle stimulating hormone concentration.
Context
GovInfoNow's records show BioMerieux SA has five other recalls on record since October 18, 2017. Other recent recalls of similar products include Menopause Test Cassette Recall (November 22, 2025), LH One Step Ovulation Test Device Recall (November 22, 2025), and GET TESTED Menopause FSH 2 Tests Recall (November 3, 2025).
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.
Where it went and when
Where it was distributed
Distributed in Kentucky.
Listed by the agency
Not listed
FDA distribution: “Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Kentucky.
Recall timeline
FDA terminated this recall 7.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.