Biomerieux Recalls VITEK 2 Streptococcus Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Streptococcus 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential loss of potency due to moisture, which fits the criteria for a moderate severity recall involving low-risk contamination or theoretical harm without reported adverse events.
Plain-English summary
Biomerieux Inc is recalling 463 cartons of VITEK 2 Streptococcus Susceptibility cards (AST-ST03), REF 421040. 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 military and government sites, as well as to numerous international locations. The source text does not specify any reported illnesses, injuries, or deaths associated with this recall.
Consumers and healthcare facilities should stop using the affected product and contact Biomerieux Inc for instructions on return or replacement.
The recalled product
- Product
- VITEK¿ 2 Streptococcus Susceptibility card (AST-ST03), IVD, REF 421040, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 463
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)
- 5420269203 22/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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