Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion… — Class II medical device recall Z-0907-2025
Ongoing recall by Hologic, Inc., reported 2025-01-22, distributed in AR, CA, CT, FL, IN, KS, LA, MA…. Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect re
| Recall number | Z-0907-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc., San Diego, CA, United States |
| Recall initiated | 2024-12-13 |
| Classified | 2025-01-14 |
| Reported by FDA | 2025-01-22 |
| Distributed | AR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV |
| Countries outside the US | CA |
| Quantity | 380 |
| Reason classes | potency, packaging |
| UPC / GTIN / UDI-DI | 15420045510890 |
| Lot numbers | 624907, 715927 |
| Model numbers | PRD-04484 |
| Expiration dates | 2025-08-15 |
Product
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Reason for recall
Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
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-0907-2025. 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.