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Qiagen Sciences LLC FDA Recalls
12 recalls on file across devices, 0 of them Class I and 10 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software VersioClass IIMar 12, 2025Identified faulty cartridges. If such a faulty cartridge is |
| QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecuClass IIJun 3, 2024Heater shaker module does not perform heating if the tempera |
| EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic anClass IIMar 4, 2024Insufficient welding leads to the heater cable becoming brit |
| QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223Class IIApr 28, 2023Faulty cartridges in the lot could result in false test resu |
| therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721Class IIJul 20, 2022Increased occurrence rate of false positive results, lead t |
| therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711Class IIJul 20, 2022Increased occurrence rate of false positive results, lead t |
| FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010Class IIJul 20, 2022Increased occurrence rate of false positive results, lead t |
| therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)Class IIFeb 25, 2022False positive or false negative G12C (12CYS) mutation resul |
| therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)Class IIFeb 25, 2022False positive or false negative G12C (12CYS) mutation resul |
| QIAcube Connect MDx, Model No. 9003070Class IINov 21, 2021During the "Load tip racks and enzymes" step of the run set- |
| QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223Class IINov 8, 2021The firm identified sixteen (16) faulty cartridges in LOT 21 |
| SARS-CoV-2 Antigen TestClass IIJan 15, 2021QIAGEN has become aware of the potential for false positive |