Z-0424-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 5, 2022
- Initiation Date
- September 22, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1818 units
Product Description
VIDAS PRG Progesterone, REF 30409-01
Reason for Recall
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI 03573026064952, Lot #s: 1008685490, 1008766980, 1008775630, 1008873180, 1008911240