Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential loss of potency in a medical diagnostic device, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards (AST-N340), Reference 419412, which are in vitro diagnostic (IVD) devices. The recall involves 10,935 cartons, with 20 cards per carton. The affected lots have codes 7800178103, 7800196203, and 7800260203, with expiration dates of May 23, 2018, June 10, 2018, and August 13, 2018, respectively.
The recall is being conducted 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 FDA has classified this as a Class II recall.
The product was distributed nationwide in the United States, including to military and government sites, as well as to numerous international locations. Users should stop using the affected cards and contact Biomerieux Inc for further instructions or a replacement.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N340), IVD, REF 419412, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 10,935
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)
- 7800178103 23/May/18 7800196203 10/Jun/18 7800260203 13/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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