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 | Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment. |
| Product | Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD. |
| Quantity | 380 |
| Distribution | AR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV, and Canada. |
| Initiated | 2024-12-13 |
| Classified | 2025-01-14 |
| Recall number | Z-0907-2025 |
| 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-0907-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95948/
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