Hologic, Inc. Recall 95948
Description: Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Hologic, Inc. Recall 95948 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0907-2025 |
Event ID | 95948 |
Event Description | Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD. |
Product Type | Devices |
Distribution | AR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV, and Canada. |
Quantity | 380 |
Recall 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. |
Device Classification | 20250122 |
Device Code Info | UDI-DI: 15420045510890, Kit Lot 715927, containing Cartridge Lot 624907, Exp. Date 2025-08-15. |
Center Classification Date | 20250114 |
Recall Initiation Date | 20241213 |
Recalling Firm | Hologic, Inc. |
Initial Notification | Letter |
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