Agency classClass IIOur severity:Moderate FDA (Devices)·Z-3179-2018·Announced 2018-09-26

bioMerieux Recalls VITEK 2 AST-P640 Cards Due to Gentamicin Error

bioMerieux is recalling VITEK 2 AST-P640 cards because some lots contain insufficient gentamicin, potentially affecting high-level resistance test 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 does not report any illnesses, injuries, or hospitalizations. The hazard is a manufacturing error affecting test accuracy rather than a direct physical injury risk, fitting the criteria for a moderate severity score.

Plain-English summary

bioMerieux, Inc. is recalling 2,538 cartons of VITEK 2 AST-P640 cards, reference number 418579. These automated reagent cards are used for antimicrobial susceptibility testing of Staphylococcus spp., Enterococcus spp., and S. agalactiae. The recall covers specific lot numbers 7400410103 and 7400697403.

The recall was initiated after a routine internal review of device history records identified that six lots of the cards were manufactured with less gentamicin than required. This error occurred during the preparation of 1500mL and 2000mL media well solutions. The insufficient drug concentration may impact the Gentamicin High-Level Resistance (ghlr01n) screen test.

The affected products were distributed worldwide, including the United States and countries such as Turkey, Austria, Switzerland, the Czech Republic, Germany, and the Netherlands. Healthcare facilities and laboratories should stop using the affected lots and contact bioMerieux for further instructions.

The recalled product

Product: VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the…
Manufacturer: bioMerieux, Inc.
Category: Medical Device — In Vitro Diagnostic
Hazard: manufacturing-error
test-inaccuracy
Affected units: 2,538

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)

Lot Numbers: 7400410103
7400697403

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · bioMerieux, Inc.

See all →

High
Biomerieux VITEK 2 AST-N461 Test Kit Recalled for Card Pouch Damage
FDA (Devices) · 2026-09-30
High
VITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
High
Susceptibility test cards recalled over false resistant antibiotic results
FDA (Devices) · 2026-02-11
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 · manufacturing error