medical Class II Updated 2022-03-23

Hologic, Inc recalls Panther Fusion Extraction Reagent-X, REF PRD-04477, For use

Recalled Product

Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA

Hazard / Issue

Failed stability specifications for reagent kits that may result in false negative test results.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Panther Fusion Extraction Reagent-X - Lot Numbers: 281375 and 291829 Components included within the kit: Panther Fusion Capture Reagent-X (FCR-X) - Lot Numbers: 281330 and 290312 Panther Fusion Enhancer Reagent-X (FER-X) - Lot Numbers281332 and 290331
View official government recall

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