Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may allow moisture to degrade antibiotic 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, and the hazard involves potential loss of potency due to moisture exposure, which fits the criteria for moderate severity involving low-risk contamination or precautionary measures without reported injuries.
Plain-English summary
Biomerieux Inc is recalling 219 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N329), REF 418631. The recall was initiated because the integrity of the product container may be compromised, exposing the product 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 source text does not specify a date range for the distribution or identify specific lot numbers beyond the reference code.
Healthcare facilities and consumers should stop using the affected cards and contact Biomerieux Inc for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N329), IVD, REF 418631, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 219
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)
- 7690205103 19/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.
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