# FDA recall Z-0546-2022

> **Microbiologics Inc** · Class III · device recall initiated 2020-12-16.

## Product

KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U.      Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)

## Reason for recall

The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly labeled. The KWIK-STIK negative control 0243U was labeled with an expiration date of 7/31/2020 when it should have been 7/31/2022.

## Distribution

US Nationwide distribution in the states of AL, CA, CO, IL, MD, MO, MS, NM, OH, OR, PA, TX, VT.

## Key facts

- **Recall number:** Z-0546-2022
- **Recalling firm:** Microbiologics Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-16
- **Report date:** 2022-02-09
- **Termination date:** 2023-01-12

- **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-0546-2022

## Citation

> AI Analytics. FDA recall Z-0546-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0546-2022. Source: US FDA. Licensed CC0.

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