VIDAS LH — Class II medical device recall Z-2588-2018

Terminated recall by bioMerieux, Inc., reported 2018-08-08, distributed nationwide. Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal

Recall number	`Z-2588-2018`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	bioMerieux, Inc., Durham, NC, United States
Recall initiated	2018-03-01
Classified	2018-07-31
Reported by FDA	2018-08-08
Terminated	2025-12-09
Distributed	Nationwide (US)
Countries outside the US	AE, AR, BD, BG, BH, BR, CA, CH, CO, CR, CZ, DE, DZ, EC, EE, EG, ES, FR, GR, GT, HK, HU, ID, IL, IN, IQ, IR, IT, JP, KE, KR, KW, LB, LK, LT, LV, MA, MX, NG, NI, NL, PA, PH, PK, PL, PT, PY, RO, RS, RU, SA, SE, TH, TN, TR, UA, UY, ZA
Quantity	5,429 units
Lot numbers	`1005940920`, `1006041520`, `1006041540`, `1006212740`, `1006274770`
Expiration dates	`2018-10-06`

Product

VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the determination of human luteinizing hormone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay)

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2588-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.