FDAFDA · Food and drugs·Recall number Z-0857-2023
VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425
Published January 11, 2023 · Recall initiated: November 9, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Biomerieux Inc
- Distributor
- US Nationwide distribution.
- Lot
- UDI/DI 03573026618940, Batch Numbers: 3122253113
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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