Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may expose the product to moisture, potentially degrading antibiotic 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 hazard involves potential loss of potency due to moisture exposure without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Biomerieux Inc is recalling 1,533 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N264, REF 413864). The recall was initiated because the integrity of the product container may be compromised, which could expose the product to moisture.
Exposure to moisture could lead to antibiotic degradation and a loss of potency. The affected product was distributed nationwide in the U.S., including to military and government sites, as well as to numerous international locations.
The source text does not specify instructions for consumers or healthcare providers regarding the disposal or return of the recalled product.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N264), REF 413864, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 1,533
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)
- 664385120 31/Mar/18 6640203103 17/Jun/18
Distribution
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 →Related recalls
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Similar recalls
- HighbioMerieux Recalls VITEK 2 Gram Positive Susceptibility Test Cards
FDA (Devices) · 2016-05-11
- ModerateBiomerieux Recalls VITEK 2 Gram-positive Susceptibility Cards Due to False Positives
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- ModeratebioMerieux Recalls VITEK 2 AST-N371 Cards Due to Compromised Seals
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- SevereBiomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards for Labeling Error
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- HighSusceptibility test cards recalled over false resistant antibiotic results
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- LowBiomerieux Recalls Vitek 2 Gram Positive Susceptibility Cards Due to Labeling Error
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