Recall archive / FDA device enforcement
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 — FDA record Z-0694-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
- Reason
- SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
- Classification
- Class II
- Recalling firm
- Hologic, Inc.
- Quantity
- 3
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0694-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 15420045515352 Kit lot 892307, Expiration: May 15, 2025. Cartridge Lot 890494 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: AK
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 1, 2025
- Recall initiation date
- Nov 8, 2024
- Center classification date
- Dec 20, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.