Class II — Hologic, Inc.
| Recalling firm | HOLOGIC, INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results. |
| Product | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 |
| Quantity | 3 |
| Distribution | US: AK |
| Initiated | 2024-11-08 |
| Classified | 2024-12-20 |
| Recall number | Z-0694-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hologic, Inc. (Z-0694-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95731/
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