Hologic, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0907-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.

Product Classification:

Class II

Date Initiated: December 13, 2024

Date Posted: January 22, 2025

Recall Number: Z-0907-2025

Event ID: 95948

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.

Status: Ongoing

Product Quantity: 380

Code Information:

UDI-DI: 15420045510890, Kit Lot 715927, containing Cartridge Lot 624907, Exp. Date 2025-08-15.

Distribution Pattern:

AR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV, and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated