Biomerieux Recalls VITEK 2 Diagnostic Test Kit Due to Storage Conditions
Biomerieux Inc has recalled the VITEK 2 Reagent AST-GP78 Test Kit nationwide due to temperature and time storage exceedances that may affect product performance. No illnesses or injuries have been reported.
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: This is an FDA Class II recall of a diagnostic test kit with compromised storage conditions. The source text does not report any illnesses, injuries, or harm. Per the severity rubric, when no illnesses/injuries are reported and the hazard is theoretical (product performance cannot be guaranteed), the score is at most 3, placing this precautionary recall in the Moderate (2) category.
Plain-English summary
Biomerieux Inc has recalled the VITEK 2 Reagent AST-GP78 Test Kit (Catalog 421051) nationwide in the United States. The recall affects 26 units with Batch Number 2782225503 and UDI/DI 03573026553982.
The recall was initiated because product storage conditions exceeded acceptable temperature and time parameters. The manufacturer states that product performance cannot be guaranteed under these circumstances.
Healthcare facilities and laboratories that received units from this batch should discontinue use and contact Biomerieux Inc for instructions on replacement or further assessment. No illnesses or injuries related to this product have been reported.
The recalled product
- Product
- VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 26
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 (2)
- UDI/DI 03573026553982
- Batch Numbers: 2782225503
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 94 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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