FDA recall Z-0694-2025
Hologic, Inc. · Class II · device
Product
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Reason for recall
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
Distribution
US: AK
Key facts
- Status
- Ongoing
- Initiation date
- 2024-11-08
- Report date
- 2025-01-01
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- San Diego, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0694-2025