Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
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 and involves a risk of harm (loss of potency) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Biomerieux Inc is recalling 3,197 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-GN09), REF 22008. The recall involves product with the code 1060251103 04/Aug/18. The product is distributed nationwide in the U.S., including military and government sites, as well as to numerous international locations.
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.
Users of the affected product should stop using the cards and contact Biomerieux Inc for further instructions or a replacement.
The recalled product
- Product
- VITEK 2 Gram Negative Susceptibility card (AST-GN09), REF 22008, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 3,197
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)
- 1060251103 04/Aug/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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