Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Container Integrity
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, and the hazard involves potential loss of potency due to moisture exposure without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Biomerieux Inc is recalling 1,468 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-GN90), REF 414779. 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. Users should check their inventory for the specific reference number and lot codes listed in the recall notice. For more information, contact Biomerieux Inc or the FDA.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-GN90), REF 414779, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 1,468
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)
- 6800159203 04/May/18 6800187403 01/Jun/18 6800290403 12/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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