Skip to main content
All Recalls

Every Qiagen Sciences Llc Recall

Sorted by most recent. Click any recall for full details.

14 recalls
High RiskFDA
Qiagen Sciences Llc
QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic an...
Diagnostic Devices·419 affected·Jun 3, 2024
High RiskFDA
Qiagen Sciences Llc
EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular bi...
Diagnostic Devices·168 affected·Mar 4, 2024
High RiskFDA
Qiagen Sciences Llc
FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
Medical Devices·9 affected·Jul 20, 2022
High RiskFDA
Qiagen Sciences Llc
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
Medical Devices·435 affected·Feb 25, 2022
High RiskFDA
Qiagen Sciences Llc
QIAcube Connect MDx, Model No. 9003070
Medical Devices·93 affected·Nov 21, 2021
High RiskFDA
Qiagen Sciences Llc
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Respiratory Devices·376 affected·Nov 8, 2021
High RiskFDA
Qiagen Sciences Llc
SARS-CoV-2 Antigen Test
Medical Devices·1,092 affected·Jan 15, 2021
High RiskFDA
Qiagen Sciences Llc
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatmen...
Medical Devices·575 affected·Dec 11, 2020
High RiskFDA
Qiagen Sciences Llc
QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and dif...
Respiratory Devices·1,474 affected·Jul 15, 2020
High RiskFDA
Qiagen Sciences Llc
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Medical Devices·530 affected·Apr 8, 2020
High RiskFDA
Qiagen Sciences Llc
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR ass...
Diagnostic Devices·11,418 affected·Jan 28, 2020
High RiskFDA
Qiagen Sciences Llc
QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automate...
Medical Devices·417 affected·Jul 2, 2019
CriticalFDA
Qiagen Sciences Llc
Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 a...
Medical Devices·1,240 affected·Jun 5, 2019
High RiskFDA
Qiagen Sciences Llc
EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isol...
Medical Devices·298 affected·Jul 23, 2018