The Recall Desk
ModerateFDA (Devices)·Z-2390-2017·Announced 2017-06-21

Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.

What this means for you

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. The hazard involves potential loss of potency due to moisture exposure, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure, fitting the Moderate criteria for low-risk contamination or functional issues without reported serious injury.

Plain-English summary

Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards (AST-N204), REF 412865. The recall involves 6,275 cartons, each containing 20 cards. The product was distributed nationwide in the U.S., including military and government sites, as well as to numerous international locations.

The recall is being conducted because the integrity of the product container may be compromised. This exposure to moisture could lead to antibiotic degradation, resulting in a loss of potency. The affected lots have expiration dates of May 23, 2018, July 21, 2018, and August 31, 2018.

Users of these products should stop using the affected cards and contact Biomerieux Inc for further instructions or a replacement.

The recalled product

Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N204), REF 412865, 20 cards per carton. .
Manufacturer
Biomerieux Inc
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
6,275

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 (1)

  • 5740178103 23/May/18 5740237203 21/Jul/18 5740278103 31/Aug/18

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 187 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 187 products in this recall →

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