Device product
Inactivated macrolide-resistant Mycoplasma genitalium
Z-0955-2022
Product summary
- Event
- Event 89887
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 ea
- Official record key
device-enforcement:Z-0955-2022
Official wording
Reason: The QC process was not adequate for the specification range.
Code information: Catalog # HE0070N; Lot HE0070-01-1 UDI: 10845357044003
Distribution pattern: US Nationwide distribution in the states of NV and VT.
Derived failure modes
-
Unknown
The QC process was not adequate for the specification range.