Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
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.
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 rather than direct physical injury or reported illness, fitting the criteria for moderate severity.
Plain-English summary
Biomerieux Inc is recalling 978 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N102), REF 22258. The product is identified by the code 3640187403 01/Jun/18. Each carton contains 20 cards.
The recall was initiated because the integrity of the product container may be compromised. This exposure to moisture could lead to antibiotic degradation, resulting in a loss of potency. The agency has classified this recall as Class II.
The product was distributed nationwide in the U.S., including military and government sites, as well as to numerous international locations. Healthcare facilities and laboratories should stop using the affected cards and contact Biomerieux Inc for further instructions.
The recalled product
- Product
- VITEK 2 Gram Negative Susceptibility card (AST-N102), REF 22258, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 978
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)
- 3640187403 01/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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