# FDA recall Z-1371-2025

> **Microbiologics Inc** · Class II · device recall initiated 2025-02-20.

## Product

Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N

## Reason for recall

The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.

## Distribution

US Nationwide distribution in the states of TX. UK.

## Key facts

- **Recall number:** Z-1371-2025
- **Recalling firm:** Microbiologics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-20
- **Report date:** 2025-03-26

- **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-1371-2025

## Citation

> AI Analytics. FDA recall Z-1371-2025. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-1371-2025. Source: US FDA. Licensed CC0.

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