FDA recall Z-1371-2025

Microbiologics Inc · Class II · device

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1371-2025