Agency classClass IIOur severity:High FDA (Devices)·Z-0831-2023·Announced 2023-01-11

ETEST Clinical Vancomycin Test Kits Recalled Due to Storage Damage

Biomerieux Inc is recalling 7 units of ETEST Clinical Vancomycin VA 256 test kits due to storage temperature excursions that may compromise test performance. Affected kits were distributed nationwide.

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: This is a FDA Class II medical device recall for a clinical laboratory test kit. No illnesses or injuries have been reported. The hazard is theoretical—storage excursion may compromise test accuracy. Per the rubric, risk-of-harm products without reported injury score at most 3 (High).

Plain-English summary

Biomerieux Inc is recalling 7 units of ETEST Clinical Vancomycin VA 256 US S30 clinical microbiology test kits. These kits are used in laboratory settings to test bacterial antibiotic resistance.

The recall was initiated because the affected kits experienced temperature and time storage conditions outside acceptable specifications. Due to this storage excursion, the performance and accuracy of these test kits cannot be guaranteed.

The affected batch (1009432150) was distributed nationwide. Facilities using these kits should discontinue use and contact Biomerieux Inc for replacements. Unreliable test results from compromised kits could affect clinical treatment decisions.

The recalled product

Product: ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486
Manufacturer: Biomerieux Inc
Category: Medical Device — Clinical Laboratory Testing
Hazard: storage-damage
performance-degradation
Affected units: 7

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 03573026378950
Batch Numbers: 1009432150

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.

See all 94 products in this recall →

Same manufacturer · Biomerieux Inc

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Same hazard · storage damage