# FDA recall Z-0544-2022

> **Microbiologics Inc** · Class III · device recall initiated 2021-02-24.

## Product

KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P.  Packaged 2 units per pack.  IVD controls.

## Reason for recall

Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.

## Distribution

US distribution to CA, FL, HI, MI, NC, NH, NJ, OK, OR, TN.      International distribution to Canada, Ecuador, France, India, Indonesia, Ireland, Japan, Mexico, South Africa, United Arab Emirates, Vietnam.

## Key facts

- **Recall number:** Z-0544-2022
- **Recalling firm:** Microbiologics Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-24
- **Report date:** 2022-02-09
- **Termination date:** 2022-07-11

- **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-0544-2022

## Citation

> AI Analytics. FDA recall Z-0544-2022. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-0544-2022. Source: US FDA. Licensed CC0.

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