Device product
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Z-0694-2025
Product summary
- Firm
- Hologic, Inc.
- Event
- Event 95731
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3
- Official record key
device-enforcement:Z-0694-2025
Official wording
Reason: SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
Code information: UDI-DI: 15420045515352 Kit lot 892307, Expiration: May 15, 2025. Cartridge Lot 890494
Distribution pattern: US: AK
Derived failure modes
-
Unknown
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.