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 degrading antibiotic potency.
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 source text describes a theoretical risk of antibiotic degradation due to moisture exposure without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Biomerieux Inc is recalling 4,810 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-GN66), REF 413398. 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 lot codes associated with this recall are 5860216103 (30/Jun/18), 5860251203 (04/Aug/18), 5860270103 (23/Aug/18), and 5860286203 (08/Sep/18).
Users of these products should check their inventory for the affected reference number and lot codes. If the product is found, it should be stopped from use and returned to the supplier or the manufacturer for further instructions.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-GN66), REF 413398, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 4,810
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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