Qiagen Sciences LLC
16 recalls on record · Latest: Apr 9, 2025
FDA Devices Moderate Apr 9, 2025
Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
FDA Devices Moderate Jul 24, 2024
QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecul…
FDA Devices Moderate Apr 17, 2024
EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applic…
FDA Devices Moderate Sep 21, 2022
QIAcube Connect MDx, Model No. 9003070
FDA Devices Moderate Sep 7, 2022
FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
FDA Devices Moderate Sep 7, 2022
therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
FDA Devices Moderate Apr 27, 2022
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
FDA Devices Moderate Jan 12, 2022
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
FDA Devices Moderate Feb 10, 2021
SARS-CoV-2 Antigen Test
FDA Devices Moderate Feb 3, 2021
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRA…
FDA Devices Moderate Sep 16, 2020
QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation…
FDA Devices Moderate Jun 17, 2020
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
FDA Devices Moderate Mar 18, 2020
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
FDA Devices Moderate Aug 28, 2019
QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purificati…
FDA Devices Critical Aug 7, 2019
Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) …
FDA Devices Moderate Nov 14, 2018