FDAFDA · Food and drugs·Recall number Z-0561-2022
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Published February 16, 2022 · Recall initiated: July 6, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Kits failed sterility testing and showed evidence of contamination.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Gentueri Inc
- Distributor
- Domestic: Illinois, Nebraska, and Wisconsin.
- Lot
- CAT#: 3300-000; Lot No.: 1029.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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