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, leading to 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 involves a risk-of-harm product (medical device) where injury has not yet been reported, and the hazard is theoretical (loss of potency), which aligns with the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Biomerieux Inc is recalling 425 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-XN01), REF 410025. The recall was initiated because the integrity of the product container may be compromised, exposing the product to moisture. This exposure could lead to antibiotic degradation and a loss of potency.
The affected product was distributed nationwide in the U.S., including military and government sites, as well as to numerous international locations. The source text does not report any illnesses or injuries associated with this recall. The hazard is theoretical, relating to the potential loss of efficacy of the antibiotic susceptibility testing rather than direct physical harm to patients.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-XN01), REF 410025, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 425
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)
- 3130227403 11/Jul/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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