The Recall Desk
ModerateFDA (Devices)·Z-2387-2017·Announced 2017-06-21

Biomerieux VITEK 2 Gram Negative Susceptibility Card Recall

Biomerieux is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may allow moisture exposure, leading to antibiotic degradation and loss of potency.

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, but the source text does not report any hospitalizations or injuries. The hazard is a theoretical loss of potency due to moisture exposure, which aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls without reported harm.

Plain-English summary

Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards (AST-N201), REF 412862. The recall involves 5,559 cartons, with 20 cards per carton. 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 compromise could expose the product to moisture, which may lead to antibiotic degradation and a loss of potency. The source text does not report any illnesses, injuries, or deaths associated with this recall.

Healthcare facilities and consumers who have this product should stop using it and contact Biomerieux Inc for further instructions or a return.

The recalled product

Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N201), REF 412862, 20 cards per carton.
Manufacturer
Biomerieux Inc
Category
Medical Device — Laboratory Diagnostic
Hazard
Affected units
5,559

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)

  • 571375320 23/Dec/17 5710177103 22/May/18 5710208203 22/Jun/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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Same hazard · moisture exposure

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