Class II

Medical Device Recall: Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.

Hologic, Inc. · December 13, 2024

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.

Distribution

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

States Affected

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

Quantity Affected

380

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0907-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Hologic, Inc. Medical Device Recall: Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD. | SafeCheck