Hologic, Inc. recalls Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.

On 11/8/24, recall notices were mailed to customers asking them to do the following: 1) Discontinue use, and discard affected kits. 2) Complete and return the customer response firm via email to molecularsupport@hologic.com If you require technical support, contact the firm's Technical Support at 1-888-484-4747, or 1-858-410-8511, or molecularsupport@hologic.com

• FDA enforcement recordOfficial FDA database entry for Z-0694-2025
• FDA 510(k) clearance · K222736The device's official FDA premarket clearance record
• FDA device classification · QOFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.3981The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Hologic, Inc.Search 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.