Z-0954-2022 Class II Terminated
FDA device recall Z-0954-2022 was initiated by Microbiologics Inc on March 24, 2022 and is designated Class II. Reason for recall: QC process was not adequate for the specification range. The recall status is terminated (terminated January 9, 2023). Affected quantity: 1 ea.
Recall Details
- Product Type
- Devices
- Report Date
- April 27, 2022
- Initiation Date
- March 24, 2022
- Termination Date
- January 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 ea
Product Description
Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
Reason for Recall
QC process was not adequate for the specification range.
Distribution Pattern
US Nationwide distribution in the state of TX.
Code Information
Catalog HE0069N; Lot HE0069-02-1 UDI: 10845357043990