Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay — Class II medical device recall Z-0694-2025
Ongoing recall by Hologic, Inc., reported 2025-01-01, distributed in AK. SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
| Recall number | Z-0694-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc., San Diego, CA, United States |
| Recall initiated | 2024-11-08 |
| Classified | 2024-12-20 |
| Reported by FDA | 2025-01-01 |
| Distributed | AK |
| Quantity | 3 |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 15420045515352 |
| Lot numbers | 890494, 892307 |
| Model numbers | PRD-07400 |
| Expiration dates | 2025-05-15 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0694-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.