Z-0504-2022 Class II Terminated
FDA device recall Z-0504-2022 was initiated by Gentueri Inc on March 18, 2021 and is designated Class II. Reason for recall: Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing. The recall status is terminated (terminated August 28, 2023). Affected quantity: 4,150 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 26, 2022
- Initiation Date
- March 18, 2021
- Termination Date
- August 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,150 units
Product Description
Gentueri Viral Transport Medium (VTM), Sterile, IVD
Reason for Recall
Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing.
Distribution Pattern
US Nationwide distribution in the state of Indiana.
Code Information
CAT #: 3300-000; Lot #: 1142