Inactivated macrolide-resistant Mycoplasma genitalium — Class II medical device recall Z-0955-2022
Terminated recall by Microbiologics Inc, reported 2022-04-27, distributed nationwide. The QC process was not adequate for the specification range.
| Recall number | Z-0955-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2022-03-22 |
| Classified | 2022-04-19 |
| Reported by FDA | 2022-04-27 |
| Terminated | 2023-01-09 |
| Distributed | Nationwide (US) |
| Quantity | 2 units |
| UPC / GTIN / UDI-DI | 10845357044003 |
| Lot numbers | HE0070-01-1 |
| Model numbers | HE0070N |
Product
Inactivated macrolide-resistant Mycoplasma genitalium
Reason for recall
The QC process was not adequate for the specification range.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0955-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.