Biomerieux Recalls VIDAS LH 60 Clinical Tests for Temperature-Induced Performance Issues
Biomerieux is recalling VIDAS LH 60 diagnostic test kits nationwide due to temperature and time excursion. The affected batch's product performance cannot be guaranteed due to storage conditions exceeding acceptable parameters.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a diagnostic test device where performance cannot be guaranteed due to temperature excursion. This qualifies as a risk-of-harm product where injury has not yet been reported, per the rubric. It is below Severe because there are no hospitalization or serious injury reports.
Plain-English summary
Biomerieux Inc is recalling VIDAS LH 60 clinical diagnostic test units (Catalog 30406-01, batch 1009483380) distributed nationwide in the United States.
The recall affects 4 units of the product. The units experienced temperature and time conditions that exceeded acceptable ranges. Because these parameters were exceeded, the manufacturer cannot guarantee the product's performance.
Patients and healthcare facilities with affected units should contact Biomerieux Inc or their medical device supplier immediately. Do not use the affected batch (1009483380, UDI/DI 03573026156930) until replacement units are obtained. This is an FDA Class II recall. For additional information, see the official FDA recall notice.
The recalled product
- Product
- VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01
- Manufacturer
- Biomerieux Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 4
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 (2)
- UDI/DI 03573026156930
- Batch Numbers: 1009483380
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 94 recalled by Biomerieux Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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