FDA-Device2020-06-03Class II
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
Hologic, Inc
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.
Sold states
US: AR, CA, FL, ID, IL, IN, LA, NM, NY, PA, TX, UT, VI, WA, WI OUS: AU, CA
Affected count
47 kits
Manufactured in
10210 Genetic Center Dr, N/A, San Diego, CA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2163-2020Don't want to check this manually?
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