Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues 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 score.
Plain-English summary
Biomerieux Inc is recalling 4,089 cartons of VITEK 2 Gram Positive Susceptibility cards (AST-P586), REF 22276. The recall involves specific lots with codes 3660165203, 3660256103, and 3660284203, manufactured in May, August, and September 2018.
The recall was initiated because the integrity of the product container may be compromised. This defect could expose the product to moisture, which may lead to antibiotic degradation and 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.
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 Positive Susceptibility card (AST-P586), REF 22276, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 4,089
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)
- 3660165203 10/May/18 3660256103 09/Aug/18 3660284203 06/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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