Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Positive 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. The hazard involves potential loss of potency due to moisture exposure, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure, fitting the Moderate criteria for low-risk contamination or precautionary recalls.
Plain-English summary
Biomerieux Inc is recalling 1,972 cartons of VITEK 2 Gram Positive Susceptibility cards (AST-GP71), REF 410750. The recall involves product with lot codes 2710228103 (dated 12/Jul/18) and 2710264203 (dated 17/Aug/18).
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 to military and government sites, as well as to numerous international locations.
Healthcare facilities and other recipients should stop using the affected product and contact Biomerieux Inc for further instructions on return or disposal.
The recalled product
- Product
- VITEK¿ 2 Gram Positive Susceptibility card (AST-GP71), REF 410750, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 1,972
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)
- 2710228103 12/Jul/18 2710264203 17/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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