Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2163-2020 — 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

U.S. FDA — Device Enforcement · United States · 2019-10-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2163-2020
Date of alert
2019-10-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Hologic, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
15420045509214
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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