FDA Device recall Z-0694-2025
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
- FDA Device
- Class II
- ongoing
- Published 2025-01-01
On 2025-01-01 the FDA classified a Class II recall of Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 by Hologic, citing SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0694-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-08 |
| Published | 2025-01-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Hologic |
| Distribution | AK |
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.
Identifiers
| code_info | UDI-DI: 15420045515352 Kit lot 892307, Expiration: May 15, 2025. Cartridge Lot 890494 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0694-2025%22
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