Lower riskMedical device recall · FDA · Published March 1, 2018
BioMérieux VIDAS LH Test Recall: Calibration Issues with Low Calibrator S1
BioMérieux recalls VIDAS LH tests with reference numbers 30406 and 30406-01 due to calibration problems using low calibrator S1. Affected lots may show decreased strip signals over time.
Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal tests confirmed a decrease of the strips signal overtime for specific lots.
Take action
Contact the company
📍Recalling firmbioMerieux, Inc.100 Rodolphe St · Durham, NC 27712-9402
✎ GovInfoNow plain-language explainer
BioMérieux is recalling specific lots of VIDAS LH tests because they may become less accurate over time, leading to invalid calibration results when using low calibrator S1. This could affect test reliability for luteinizing hormone measurements. Read more at govinfonow.com/recall/71840-biom-rieux-vidas-lh-test-recall-calibration-issues-with-low.
“BioMérieux VIDAS LH Test Recall: Calibration Issues with Low Calibrator S1.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71840-biom-rieux-vidas-lh-test-recall-calibration-issues-with-low. Based on FDA recall #Z-2588-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2588-2018%22&limit=1).
The FDA announced on March 1, 2018, that bioMerieux, Inc. is recalling VIDAS LH test kits due to invalid calibration hazards. The agency issued recall number Z-2588-2018 for the affected automated quantitative tests.
How to tell if you have it
Brand: BioMérieux
Product: VIDAS LH
Reference No. 30406, Lot No. 1005940920 (Exp. Date 08/06/2018)
Reference No. 30406, Lot No. 1006041540 (Exp. Date 10/06/2018)
Reference No. 30406, Lot No. 1006212740 (Exp. Date 12/21/2018)
Reference No. 30406, Lot No. 1006274770 (Exp. Date 01/29/2019)
Reference No. 30406-01, Lot No. 1006041520 (Exp. Date 10/06/2018)
The hazard
According to the FDA, several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal tests confirmed a decrease of the strips signal overtime for specific lots.
Context
GovInfoNow's records show Biomerieux Inc has 36 other recalls on record since 2017-07-12. Other recent recalls of similar products include LH One Step Ovulation Test Device Recall (2025-11-22), Fujirebio Lumipulse G Amyloid 1-42 Plasma Calibrators Recall (2025-12-11), and hCG Pregnancy Tests May Give False Positives - Alere Recall (2026-08-20).
How to tell if you have this one
Check for reference numbers 30406 or 30406-01 on the test packaging. Look for specific lot numbers: 1006041520 (exp. 10/06/2018), 1005940920 (exp. 08/06/2018), 1006041540 (exp. 10/06/2018), 1006212740 (exp. 12/21/2018), or 1006274770 (exp. 01/29/2019).
Brand
BioMérieux
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Test Lot Numbers
Look for lot numbers 1006041520, 1005940920, 1006041540, 1006212740, or 1006274770 on the test packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide Distribution - US Nationwide in the state of Arizona and North Carolina. Distributed internationally to Algeria, Algeria, Angola, Argentina, Bahrain, Bangladesh, Belarus, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cameroon,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, North Carolina.
Recall timeline
FDA terminated this recall 7.8 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-2588-2018 (March 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2588-2018 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.