medical Class II Updated 2020-06-03

Hologic, Inc recalls Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE,

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: AR, CA, FL, ID, IL, IN, LA, NM, NY, PA, TX, UT, WA, WI

Lot/Code Info: Panther Fusion Extraction Reagent-S Lot number: 258402 Panther Fusion Capture Reagent-S Lot number: 257472 Panther Fusion Enhancer Reagent-S Lot number: 257473

View official government recall

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