FDA Recalls VITEK 2 Antibiotic Susceptibility Test Kits Due to Storage Excursion
Biomerieux Inc. is recalling VITEK 2 REAGENT AST-GN69 test kits nationwide due to temperature and time excursions during storage that may compromise product performance.
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 product is a medical device critical to clinical decision-making. Storage condition excursions that compromise test performance create a risk of inaccurate results, which could lead to inappropriate antibiotic selection. This fits the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomerieux Inc. is recalling the VITEK 2 REAGENT AST-GN69 TEST KIT (20 cards, Catalog 413400) distributed nationwide. Batch number 5892256103 is affected. The recall involves approximately 30 units.
The product was exposed to temperature and time conditions outside the specified range during storage or distribution. As a result, the manufacturer states that product performance cannot be guaranteed. The VITEK 2 test kit is used in clinical laboratories to determine antibiotic susceptibility patterns for bacterial isolates, which is critical information for selecting appropriate antibiotic treatment.
Clinical laboratories and healthcare facilities should immediately cease use of affected kits and contact Biomerieux Inc. for instructions on product return or replacement. Laboratory directors should verify their facilities do not have kits from the recalled batch number. If results from these kits have been reported to patient records, healthcare providers should consider whether any reported results may be unreliable.
The recalled product
- Product
- VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400
- Manufacturer
- Biomerieux Inc
- Affected units
- 30
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 03573026398460
- Batch Numbers: 5892256103
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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