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, 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, but the hazard is a theoretical loss of potency due to moisture exposure with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomerieux Inc is voluntarily recalling 500 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N285), REF 414740. The recall was initiated because the integrity of the product container may be compromised, which could expose the product to moisture. This exposure may lead to antibiotic degradation and a loss of potency.
The affected product was distributed nationwide in the U.S., including to military and government sites, as well as to numerous international locations. The specific code for the recalled product is 7050141203 16/Apr/18.
Healthcare facilities and consumers should stop using the affected cards and contact Biomerieux Inc for further instructions or a refund.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N285), REF 414740, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 500
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)
- 7050141203 16/Apr/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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