Qiagen Sciences LLC

FDA Regulatory Profile

Summary

Total Recalls
23 (2 Class I)
510(k) Clearances
0
Inspections
8
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1504-2025Class IIBrand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691March 12, 2025
Z-2353-2024Class IIQIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucJune 3, 2024
Z-1508-2024Class IIEZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molMarch 4, 2024
Z-1683-2023Class IIQIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference NumbeApril 28, 2023
Z-1651-2022Class IItherascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711July 20, 2022
Z-1652-2022Class IIFGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010July 20, 2022
Z-1650-2022Class IItherascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721July 20, 2022
Z-0952-2022Class IItherascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)February 25, 2022
Z-0951-2022Class IItherascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)February 25, 2022
Z-1746-2022Class IIQIAcube Connect MDx, Model No. 9003070November 21, 2021
Z-0455-2022Class IIQIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223November 8, 2021
Z-0941-2021Class IISARS-CoV-2 Antigen TestJanuary 15, 2021
Z-0937-2021Class IItherascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patiDecember 11, 2020
Z-2938-2020Class IIQIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended July 15, 2020
Z-2290-2020Class IItherascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121April 8, 2020
Z-1636-2020Class IIAmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US DistFebruary 21, 2020
Z-1476-2020Class IIQIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycliJanuary 28, 2020
Z-2319-2019Class IIQIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrJuly 2, 2019
Z-2088-2019Class IFilter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsympJune 5, 2019
Z-1891-2019Class IIRNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system intended foMay 6, 2019