Biomerieux VITEK 2 Gram Negative Susceptibility Card Recall
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity may be compromised, exposing the product to moisture and causing antibiotic degradation.
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 voluntary precautionary recall.
Plain-English summary
Biomerieux Inc is recalling 536 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N215, REF 413065). 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.
The affected product was distributed nationwide in the U.S., including to military and government sites, as well as to numerous international locations. The specific code information for the recalled product is 6150143203 18/Apr/18.
Users of this product should check their inventory for the specific reference number and code information listed above. If the product matches the description, it should be removed from use and returned to the supplier or the manufacturer for further instructions.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N215), REF 413065, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 536
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)
- 6150143203 18/Apr/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.
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Similar recalls
- HighbioMerieux Recalls VITEK 2 Gram Positive Susceptibility Test Cards
FDA (Devices) · 2016-05-11
- SevereBiomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards for Labeling Error
FDA (Devices) · 2016-05-18
- 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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- LowBiomerieux Recalls Vitek 2 Gram Positive Susceptibility Cards Due to Labeling Error
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- SevereBiomerieux Vitek 2 Gram Positive Test Cards Recalled for Labeling Error
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