# FDA recall Z-0543-2022

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

## Product

KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P.  Packaged 2 units per pack.  IVD controls.

## Reason for recall

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

## Distribution

Worldwide distribution - US distribution in the states of GA, MS, MT, NC, NM, NV, TN, TX, WA, WI and the countries of  Brazil, Canada, China, Colombia, Dominican Republic, France, India, Ireland, Japan, Mexico, Oman, Philippines, Romania, South Africa, Turkey, United Arab Emirates.

## Key facts

- **Recall number:** Z-0543-2022
- **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-0543-2022

## Citation

> AI Analytics. FDA recall Z-0543-2022. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-0543-2022. Source: US FDA. Licensed CC0.

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