Agency classClass IIOur severity:High FDA (Devices)·Z-0792-2023·Announced 2023-01-11

VITEK 2 AST-GP67 Reagent Test Kit Recalled Due to Storage Condition Excursion

Biomerieux Inc. is recalling VITEK 2 Antibiotic Susceptibility Test Kits (AST-GP67) due to storage temperature and time conditions exceeding acceptable limits, which cannot guarantee product performance.

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 an FDA Class II recall of a medical diagnostic device where storage temperature and time conditions exceeded acceptable limits. The affected test kits present a risk-of-harm through potentially inaccurate diagnostic results, though no illnesses or test failures have been reported.

Plain-English summary

Biomerieux Inc. is recalling the VITEK 2 Reagent AST-GP67 Test Kit (Catalog 22226), a medical device used for antibiotic susceptibility testing in laboratory and clinical settings.

The recall was initiated after it was determined that product in batch 1322258403 experienced storage conditions—specifically temperature and time—that exceeded the acceptable range. When storage parameters are exceeded, product performance cannot be guaranteed.

The affected product was distributed nationwide in the United States. Facilities that may have received this batch should identify affected product and contact Biomerieux Inc. regarding the recall.

The recalled product

Product: VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226
Manufacturer: Biomerieux Inc
Category: Medical Device — Diagnostic Reagent Kit
Hazard: reagent-degradation
storage-temperature-excursion
test-performance-failure
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 03573026242060
Batch Numbers: 1322258403

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

See all →

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High
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High
Susceptibility test cards recalled over false resistant antibiotic results
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High
Antimicrobial susceptibility test cards recalled over false colistin resistance results
FDA (Devices) · 2025-10-08
Severe
VITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk
FDA (Devices) · 2024-05-01

Same hazard · reagent degradation