Verona, WI, United States
Gentueri Inc recalls
2 recalls recorded since 2018, most recently on 18 March 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 18 March 2021
- Terminated
- 28 August 2023
- Reason
- Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing.
- Distribution
- US Nationwide distribution in the state of Indiana.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0504-2022
- Gentueri Viral Transport Medium (VTM), Sterile, IVD
Terminated Class II Medical devices
- Recall started
- 6 July 2020
- Terminated
- 12 December 2023
- Reason
- Kits failed sterility testing and showed evidence of contamination.
- Distribution
- Domestic: Illinois, Nebraska, and Wisconsin.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0561-2022
- Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.