VITEK 2 Antibiotic Susceptibility Test Kits Recalled Due to Storage Condition Failures
Biomerieux Inc is recalling VITEK 2 Reagent AST-GN73 test kits nationwide because they were stored outside proper temperature and time ranges, potentially compromising test accuracy.
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: This is a FDA Class II recall of a diagnostic test kit with storage condition failures that could result in inaccurate test results. No illnesses or injuries have been reported, but unreliable antimicrobial susceptibility testing presents a risk of harm to patients who may receive inappropriate antibiotic treatments based on inaccurate testing.
Plain-English summary
Biomerieux Inc is recalling VITEK 2 Reagent AST-GN73 test kits (Catalog 413404) distributed nationwide. The recall involves 64 units, Batch Number 5932237403. These test kits were stored outside their specified temperature and time ranges.
When test kits are exposed to improper storage conditions, product performance cannot be guaranteed. The VITEK 2 Reagent AST-GN73 is used for antimicrobial susceptibility testing in healthcare and laboratory settings to determine appropriate antibiotic selection. Test results from kits stored outside specified conditions may be unreliable, potentially leading to incorrect clinical decisions.
The recalled product
- Product
- VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404
- Manufacturer
- Biomerieux Inc
- Affected units
- 64
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 03573026398507
- Batch Numbers: 5932237403
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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