Reported Jan 22, 2025 · Ongoing
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Hologic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc. · 10210 Genetic Center Dr · San Diego, CA · 92121-4362
Is this the product you have?
- Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
- Lot codes and dates
- UDI-DI
15420045510890Kit Lot 715927containing Cartridge Lot 624907Exp. Date 2025-08-15
- UDI-DI
- Amount recalled
- 380
Where it was sold
Why it was recalled
Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
This product could cause temporary or reversible health problems — stop using it.
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