# FDA recall Z-0955-2022

> **Microbiologics Inc** · Class II · device recall initiated 2022-03-22.

## Product

Inactivated macrolide-resistant Mycoplasma genitalium

## Reason for recall

The QC process was not adequate for the specification range.

## Distribution

US Nationwide distribution in the states of NV and VT.

## Key facts

- **Recall number:** Z-0955-2022
- **Recalling firm:** Microbiologics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-03-22
- **Report date:** 2022-04-27
- **Termination date:** 2023-01-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Cloud, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0955-2022

## Citation

> AI Analytics. FDA recall Z-0955-2022. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0955-2022. Source: US FDA. Licensed CC0.

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