Qiagen Sciences Llc
Germantown, MD
This page shows every FDA and USDA recall linked to Qiagen Sciences Llc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
21
Total Recalls
2016
First Recall
2025
Most Recent
Brand Name: QIAstat-Dx
Product Name: QIAstat-Dx Respiratory Panel Plus
Reference Number (REF): 691224
Software...
Mar 31, 2025
· Device
Open, Classified
QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids...
Jul 12, 2024
· Device
Open, Classified
EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular dia...
Apr 10, 2024
· Device
Open, Classified
QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
Jun 2, 2023
· Device
Open, Classified
therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US)
REF 874711
Jul 20, 2022
· Device
Open, Classified
FGFR RGQ RT-PCR Kit (RUO, not IVD)
REF 8747010
Jul 20, 2022
· Device
Open, Classified
therascreen FGFR RGQ RT-PCR kit (US IVD)
REF 874721
Jul 20, 2022
· Device
Open, Classified
therascreen KRAS RGQ PCR Kit (24)
Model Number(s): REF 870021 (US IVD)
Feb 25, 2022
· Device
Open, Classified
therascreen KRAS RGQ PCR Kit (24)
REF 874052 (Japan IVD, not released in the USA)
Feb 25, 2022
· Device
Open, Classified
QIAcube Connect MDx, Model No. 9003070
Nov 21, 2021
· Device
Open, Classified
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Nov 8, 2021
· Device
Terminated
SARS-CoV-2 Antigen Test
Jan 15, 2021
· Device
Terminated
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who m...
Dec 11, 2020
· Device
Terminated
QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qu...
Jul 15, 2020
· Device
Terminated
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Apr 8, 2020
· Device
Terminated
AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution,...
Feb 21, 2020
· Device
Terminated
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and rea...
Jan 28, 2020
· Device
Terminated
Filter-Tips, 1500 ul (1024 tips/kitbox),
REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS...
Aug 1, 2019
· Device
Terminated
QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is d...
Jul 2, 2019
· Device
Open, Classified
EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760
Product Usage:
The EZ1 Advanced XL is designed t...
Jul 23, 2018
· Device
Terminated
QFT TB Antigen Tube.
QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis in...
Feb 2, 2016
· Device
Terminated