FDA recall Z-0955-2022
Microbiologics Inc · Class II · device
Product
Inactivated macrolide-resistant Mycoplasma genitalium
Reason for recall
The QC process was not adequate for the specification range.
Distribution
US Nationwide distribution in the states of NV and VT.
Key facts
- Status
- Terminated
- Initiation date
- 2022-03-22
- Report date
- 2022-04-27
- Termination date
- 2023-01-09
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Saint Cloud, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0955-2022