Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, leading to 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. The hazard involves potential loss of potency due to moisture exposure, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure, fitting the Moderate category for low-risk contamination or functional issues without reported harm.
Plain-English summary
Biomerieux Inc is recalling 2,793 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-GN74), REF 413941. The recall involves specific lot codes: 5940153203 (28/Apr/18), 5940255203 (08/Aug/18), and 5940292403 (14/Sep/18).
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 product was distributed nationwide in the U.S., including military and government sites, as well as to numerous international locations.
Users should check their inventory for the affected lot codes and stop using the product if the container integrity is compromised. Biomerieux Inc is the recalling firm.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-GN74), REF 413941, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 2,793
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)
- 5940153203 28/Apr/18 5940255203 08/Aug/18 5940292403 14/Sep/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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