Recall Z-1371-2025— Microbiologics Inc

Name: FDA recall Z-1371-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-20

Class II · Ongoing

Class II FDA medical device recall by Microbiologics Inc, initiated 2025-02-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N. Reason: The A549 human cell target (human cells for sample adequacy control) may give a late Ct value..

Recalling firm: Microbiologics Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-02-20
Firm location: Saint Cloud, MN, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.