Recall Z-1454-2025— Microbiologics Inc

Name: FDA recall Z-1454-2025
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 Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N. Reason: The RSV target may give a late Ct value and could potentially not pass QC..

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 Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N

Reason for recall

The RSV target may give a late Ct value and could potentially not pass QC.

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