Device product
Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
Z-0954-2022
Product summary
- Event
- Event 89886
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 ea
- Official record key
device-enforcement:Z-0954-2022
Official wording
Reason: QC process was not adequate for the specification range.
Code information: Catalog HE0069N; Lot HE0069-02-1 UDI: 10845357043990
Distribution pattern: US Nationwide distribution in the state of TX.
Derived failure modes
-
Unknown
QC process was not adequate for the specification range.