FDAOctober 10, 2019device

Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214

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

The hazard

Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay in treatment.

What to do

FDA enforcement status: Ongoing

Brands named

hologic

UPCs

15420045509214

Recall history

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

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