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Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, un...

FDA Recall #Z-1371-2025 — Class II — February 20, 2025

Recall #Z-1371-2025 Date: February 20, 2025 Classification: Class II Status: Ongoing

Product Description

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.

Recalling Firm

Microbiologics Inc — Saint Cloud, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

6 units

Distribution

US Nationwide distribution in the states of TX. UK.

Code Information

UDI-DI: 10845357043563; Lot Number: HE0065-29

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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