Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2350-2017·Announced 2017-06-21

Biomerieux Recalls VITEK 2 Fungal Susceptibility Cards Due to Container Integrity Issues

Biomerieux Inc is recalling VITEK 2 Fungal Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.

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, and the source text describes a potential loss of potency due to moisture exposure without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Biomerieux Inc is voluntarily recalling 488 cartons of VITEK 2 Fungal Susceptibility cards (AST-YS01), REF 22108. The recall is due to a potential compromise in the integrity of the product container, which may expose the cards to moisture. This exposure could lead to antibiotic degradation and a loss of potency in the product.

The affected product was distributed nationwide in the United States, including to military and government sites. The cards were also distributed to numerous international locations, including Canada, Mexico, and various countries in Europe, Asia, Africa, and South America. The specific lot code associated with the recall is 2810176403, with an expiration date of May 21, 2018.

Healthcare facilities and consumers should stop using the affected VITEK 2 Fungal Susceptibility cards immediately. Users should contact Biomerieux Inc for further instructions on how to return or dispose of the product. This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: VITEK¿ 2 Fungal Susceptibility card (AST-YS01), REF 22108, 20 cards per carton.
Manufacturer: Biomerieux Inc
Category: Medical Device — In Vitro Diagnostics
Hazard: loss-of-potency
moisture-exposure
Affected units: 488

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)

2810176403 21/May/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 →

Same manufacturer · Biomerieux Inc

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Same hazard · loss of potency