# FDA recall Z-0584-2022

> **Microbiologics Inc** · Class II · device recall initiated 2020-10-01.

## Product

QC Sets and Panels: KWIK-STIK" 2 Pack.  Common Name: QC Sets and Panels GP Comprehensive QC Set.      Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2.

## Reason for recall

Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NM, NY, OH, OK, OR, PR, SC, TN, TX, VA, VT, WA, WV and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, FRANCE, GEORGIA, GERMANY, GUATAMALA, HONG KONG, INDIA, INDONESIA, IRELAND, ITALY, JAPAN, JORDAN, LATVIA, MEXICO, NETHERLANDS, PERU, PHILIPPINES, POLAND, ROMANIA, SAUDI ARABIA, SOUTH AFRICA, SWITZERLAND, UNITED ARAB EMIRATES, VIETNAM.

## Key facts

- **Recall number:** Z-0584-2022
- **Recalling firm:** Microbiologics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-01
- **Report date:** 2022-02-16
- **Termination date:** 2022-07-07

- **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-0584-2022

## Citation

> AI Analytics. FDA recall Z-0584-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0584-2022. Source: US FDA. Licensed CC0.

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