Microbiologics Inc recalls Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet)

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

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

An Urgent Medical Device Recall notification letter dated 2/20/25 was sent to customers. INSTRUCTIONS: 1. REVIEW lab procedures to understand how this information affects your usage 2. DISCARD affected product. 3. COMPLETE the response form provided. 4. RETURN the response form to recall@microbiologics.com 5. KEEP this letter for your records. 6. NOTIFY other facilities or customers to whom the product may have been distributed or transferred. 7. CONTACT Microbiologics if a replacement kit is needed. Microbiologics is dedicated to ensuring the success of your quality control processes. Please contact our Recall Support team at 320.229.7080 or recall@microbiologics.com with questions or concerns. Collect calls may be made.

• FDA enforcement recordOfficial FDA database entry for Z-1371-2025
• FDA device classification · OHQOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1660The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Microbiologics IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.