Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may expose the product to moisture, potentially 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. The hazard is a theoretical loss of potency due to moisture exposure, with no reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomerieux Inc is recalling 708 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-GN77), REF 413434. The recall involves 20 cards per carton. The product was 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 source text does not report any illnesses or injuries associated with this recall.
Healthcare facilities and distributors should stop using the affected product and contact Biomerieux Inc for instructions on return or disposal.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-GN77), REF 413434, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 708
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)
- 5970239203 23/Jul/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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