Recall Z-0561-2022— Gentueri Inc
Class II · Terminated
Class II FDA medical device recall by Gentueri Inc, initiated 2020-07-06, terminated 2023-12-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab. Reason: Kits failed sterility testing and showed evidence of contamination..
- Recalling firm
- Gentueri Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-06
- Terminated
- 2023-12-12
- Firm location
- Verona, WI, United States
Product description
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Reason for recall
Kits failed sterility testing and showed evidence of contamination.
Data sourced from openFDA. This site is unofficial and independent of the FDA.