FDA Device recall Z-0955-2022
Inactivated macrolide-resistant Mycoplasma genitalium
- FDA Device
- Class II
- terminated
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of Inactivated macrolide-resistant Mycoplasma genitalium by Microbiologics, citing the QC process was not adequate for the specification range.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0955-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-22 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Microbiologics |
| Distribution | US |
Product
Inactivated macrolide-resistant Mycoplasma genitalium
Reason
The QC process was not adequate for the specification range.
Identifiers
| code_info | Catalog # HE0070N; Lot HE0070-01-1 UDI: 10845357044003 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0955-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.