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FDADecember 13, 2024device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.

What to do

FDA enforcement status: Ongoing

Brands named

hologic

UPCs

15420045510890

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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