Agency classClass IIOur severity:High FDA (Devices)·Z-0837-2023·Announced 2023-01-11

VITEK 2 Antibiotic Susceptibility Test Kits Recalled for Storage Condition Exceedance

Biomerieux is recalling VITEK 2 REAGENT AST-GN80 test kits due to temperature and time excursions during storage or handling. Product performance cannot be guaranteed for affected units.

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 Class II FDA medical device recall involving a diagnostic test with potential for patient harm if inaccurate results are reported and used for clinical decisions. Although no illnesses or injuries have been reported, the product qualifies as a risk-of-harm device where injury has not yet been reported, per the rubric criterion for a score of 3.

Plain-English summary

Biomerieux Inc is recalling VITEK 2 REAGENT AST-GN80 TEST KIT (catalog number 413437) nationwide in the United States. This is a Class II recall affecting 15 units with batch number 6702239503.

The recall was initiated because the product was exposed to temperatures and time periods that exceeded acceptable limits during storage or handling. As a result, the performance of the affected test kits cannot be guaranteed.

VITEK 2 is an antibiotic susceptibility testing system used in clinical laboratories to guide antibiotic therapy decisions. If the reagents have degraded due to improper storage conditions, test results may be inaccurate, potentially affecting clinical decision-making and patient treatment.

Healthcare providers and laboratories with affected units should discontinue use and contact Biomerieux for instructions on returning the product or obtaining replacement kits.

The recalled product

Product: VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437
Manufacturer: Biomerieux Inc
Category: Medical Device — Diagnostic Test Reagent
Hazard: reagent-degradation
test-inaccuracy
Affected units: 15

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 03573026399023
Batch Numbers: 6702239503

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 · reagent degradation