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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0907-2025
Event ID95948
Event DescriptionPanther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Product TypeDevices
DistributionAR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV, and Canada.
Quantity380
Recall ReasonPotential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
Device Classification20250122
Device Code InfoUDI-DI: 15420045510890, Kit Lot 715927, containing Cartridge Lot 624907, Exp. Date 2025-08-15.
Center Classification Date20250114
Recall Initiation Date20241213
Recalling FirmHologic, Inc.
Initial Notification Letter
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