# FDA recall Z-1740-2022

> **Microbiologics Inc** · Class III · device recall initiated 2022-07-27.

## Product

Helix Elite Inactivated Standard, labeled as:     a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N;   b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N

## Reason for recall

Product not registered for use in the UK

## Distribution

International distribution to the country of United Kingdom.

## Key facts

- **Recall number:** Z-1740-2022
- **Recalling firm:** Microbiologics Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-07-27
- **Report date:** 2022-09-21
- **Termination date:** 2024-08-02

- **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-1740-2022

## Citation

> AI Analytics. FDA recall Z-1740-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1740-2022. Source: US FDA. Licensed CC0.

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