# FDA recall Z-0302-2021

> **Microbiologics Inc** · Class II · device recall initiated 2020-10-08.

## Product

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 or 6.

## Reason for recall

KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.

## Distribution

Distribution in US, Brazil, Canada, Costa Rica, France, Germany, Ireland, Italy, Japan, New Zealand, Sweden, and United Kingdom.

## Key facts

- **Recall number:** Z-0302-2021
- **Recalling firm:** Microbiologics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-08
- **Report date:** 2020-11-04
- **Termination date:** 2022-11-17

- **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-0302-2021

## Citation

> AI Analytics. FDA recall Z-0302-2021. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-0302-2021. Source: US FDA. Licensed CC0.

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