Z-0955-2022 Class II Terminated
FDA device recall Z-0955-2022 was initiated by Microbiologics Inc on Mar 22, 2022 and is designated Class II. Reason for recall: The QC process was not adequate for the specification range. The recall status is terminated (terminated Jan 9, 2023). Affected quantity: 2 ea.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 27, 2022
- Initiation Date
- Mar 22, 2022
- Termination Date
- Jan 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 ea
Product Description
Inactivated macrolide-resistant Mycoplasma genitalium
Reason for Recall
The QC process was not adequate for the specification range.
Distribution Pattern
US Nationwide distribution in the states of NV and VT.
Code Information
Catalog # HE0070N; Lot HE0070-01-1 UDI: 10845357044003
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0955-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026