Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2588-2018·Announced 2018-08-08

bioMerieux Recalls VIDAS LH Test Kits Due to Calibration Issues

bioMerieux, Inc. is recalling VIDAS LH test kits because internal tests confirmed a decrease in strip signal over time, leading to invalid calibration results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a technical defect (decreased signal) without reporting any patient injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm has not been reported.

Plain-English summary

bioMerieux, Inc. is recalling 5,429 units of VIDAS LH, Reference Numbers 30406 and 30406-01. This product is an automated quantitative test used on VIDAS family instruments to determine human luteinizing hormone in human serum or plasma using the ELFA technique.

The recall was initiated after several complaints were received regarding invalid calibration with low calibrator S1. Internal tests by the manufacturer confirmed a decrease in the strips' signal over time for specific lots. The affected lots include Reference No. 30406-01, Lot No. 1006041520 (Exp. Date 10/06/2018), and Reference No. 30406, Lot Nos. 1005940920 (08/06/2018), 1006041540 (10/06/2018), 1006212740 (12/21/2018), and 1006274770 (01/29/2019).

The products were distributed worldwide, including nationwide in the United States (specifically noted in Arizona and North Carolina) and to numerous international locations. Users of these test kits should stop using the affected lots and contact bioMerieux, Inc. for further instructions or replacement.

The recalled product

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…
Manufacturer: bioMerieux, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: invalid-calibration
test-accuracy
Affected units: 5,429

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

Reference No. 30406-01
Lot No. 1006041520 (Exp. Date 10/06/2018)
Reference No. 30406
Lot No. (Exp. Date): 1005940920 (08/06/2018)
1006041540 (10/06/2018)
1006212740 (12/21/2018)
1006274770 (01/29/2019)

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Same manufacturer · bioMerieux, Inc.

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