# FDA recall Z-0636-2022

> **Microbiologics Inc** · Class III · device recall initiated 2017-03-02.

## Product

KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus.      Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. A KWIK-STIK" catalog number ending in  P  is a duopak and contains two KWIKSTIK" sticks.

## Reason for recall

Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.

## Distribution

International distribution in the countries of Canada and Germany.

## Key facts

- **Recall number:** Z-0636-2022
- **Recalling firm:** Microbiologics Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-03-02
- **Report date:** 2022-02-16
- **Termination date:** 2022-04-22

- **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-0636-2022

## Citation

> AI Analytics. FDA recall Z-0636-2022. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-0636-2022. Source: US FDA. Licensed CC0.

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