FDAFDA · Food and drugs·Recall number Z-0694-2025
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Published January 1, 2025 · Recall initiated: November 8, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hologic, Inc.
- Distributor
- US: AK
- Lot
- UDI-DI: 15420045515352 Kit lot 892307, Expiration: May 15, 2025. Cartridge Lot 890494
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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