Z-0561-2022 Class II Terminated
FDA device recall Z-0561-2022 was initiated by Gentueri Inc on July 6, 2020 and is designated Class II. Reason for recall: Kits failed sterility testing and showed evidence of contamination. The recall status is terminated (terminated December 12, 2023). Affected quantity: 13,975 units (2 mL in a 15 mL conical tube).
Recall Details
- Product Type
- Devices
- Report Date
- February 16, 2022
- Initiation Date
- July 6, 2020
- Termination Date
- December 12, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,975 units (2 mL in a 15 mL conical tube)
Product Description
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Reason for Recall
Kits failed sterility testing and showed evidence of contamination.
Distribution Pattern
Domestic: Illinois, Nebraska, and Wisconsin.
Code Information
CAT#: 3300-000; Lot No.: 1029.