Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially degrading antibiotic potency.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential loss of potency in a diagnostic device, which poses a risk of harm through inaccurate results, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards (AST-GN67), REF 413399. The recall involves 12,799 cartons, each containing 20 cards. The product is an in vitro diagnostic (IVD) device used for susceptibility testing.
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 as a Class II recall.
The product was distributed nationwide in the U.S., including military and government sites, as well as to numerous international locations. Users should stop using the affected product and contact Biomerieux Inc for further instructions or a replacement.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-GN67), IVD, REF 413399, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 12,799
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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