# FDA recall Z-0587-2022

> **Microbiologics Inc** · Class II · device recall initiated 2020-02-18.

## Product

QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set.  KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms

## Reason for recall

Tests returning incorrect susceptible results.  High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.

## Distribution

Worldwide Distribution.  US nationwide including Puerto Rico and Guam, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia/Hrvatska, Curacao, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan,  Democratic People's Republic of Korea, Republic of Korea, Kuwait, Lebanon, Malaysia, Netherlands, New Zealand, Panama, Peru, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

## Key facts

- **Recall number:** Z-0587-2022
- **Recalling firm:** Microbiologics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-18
- **Report date:** 2022-02-16
- **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-0587-2022

## Citation

> AI Analytics. FDA recall Z-0587-2022. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0587-2022. Source: US FDA. Licensed CC0.

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