# FDA recall Z-0699-2022

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

## Product

Helix Elite" Molecular Standards: Inactivated Standard.  Inactivated Respiratory Syncytial Virus A Strain Long.     Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2¿C-25¿C through the expiration date. Each lyophilized pellet is packaged in a single-use foil pouch. Each kit contains 5 unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.

## 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-0699-2022
- **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-0699-2022

## Citation

> AI Analytics. FDA recall Z-0699-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0699-2022. Source: US FDA. Licensed CC0.

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