VITEK 2 Antimicrobial Susceptibility Test Kits Recalled for Temperature Exposure
Biomerieux is recalling VITEK 2 AST-GN70 test kits nationwide due to temperature and time excursions that may compromise test performance and diagnostic reliability.
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 Class II medical device diagnostic tool. Temperature and time excursions may compromise test performance and reliability, creating a risk of incorrect diagnostic results. No illnesses or adverse events have been reported, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomerieux Inc is recalling VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS (Catalog 413401) nationwide. Batch numbers 5902225503 and 5902279403 are affected.
The kits are being recalled because they were exposed to temperatures and times outside the required ranges. When subjected to these conditions, the product performances cannot be guaranteed. The VITEK 2 AST-GN70 is an antimicrobial susceptibility test kit used in clinical laboratories to determine bacterial resistance to antibiotics.
The recalled product
- Product
- VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401
- Manufacturer
- Biomerieux Inc
- Affected units
- 120
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 (3)
- UDI/DI 03573026398477
- Batch Numbers: 5902225503
- 5902279403
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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