# FDA recall Z-0697-2022

> **Microbiologics Inc** · Class II · device recall initiated 2017-06-06.

## Product

Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms:  1. S. Typhimurium derived from NCTC 74,   2. S. sonnei derived from NCTC 12984,   3. E. coli derived from CDC 2010C-3114 (STEC),   4. C. jejuni derived from NCTC 11322,   5. P. shigelloides derived from NCTC 10363,   6. Y. enterocolitica derived from NCTC 11174,   7. E. coli derived from NCTC 11602 (ETEC),   8. V. parahaemolyticus derived from NCTC 13209

## Reason for recall

Real-time shelf life testing failed at 24 months

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AK, CA, DC, FL, IA, ID, KS, LA, MD, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SC, TX, VA, WA, WV and the countries of Australia, Belgium, Canada, India, United Kingdom.

## Key facts

- **Recall number:** Z-0697-2022
- **Recalling firm:** Microbiologics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-06
- **Report date:** 2022-03-09
- **Termination date:** 2023-01-17

- **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-0697-2022

## Citation

> AI Analytics. FDA recall Z-0697-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0697-2022. Source: US FDA. Licensed CC0.

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