Qiagen Recalls
6 recalls on record · December 27, 2017 to October 11, 2023 · Medical Devices
Recalls by year
17
18
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 11, 2023Medical DevicesFDA
Qiagen GmbH recalls therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection o
Hazard: Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAIL. A dilution of CRC tissue could lead to a false negative result. To remove ambiguity, an alteration must be made to the S the sample result with this flag should be interpreted as invalid
August 2, 2023Medical DevicesFDA
Qiagen GmbH recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intende
Hazard: Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
August 2, 2023Medical DevicesFDA
Qiagen GmbH recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) sample
Hazard: Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
August 2, 2023Medical DevicesFDA
Qiagen GmbH recalls QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-C
Hazard: If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that lead to a run abortion will occur and no results will be reported
August 8, 2018Medical DevicesFDA
QIAGEN recalls EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
Hazard: Underfilled reagent well that could lead to incorrect results
December 27, 2017Medical DevicesFDA
Qiagen, GmbH recalls QIAamp DSP Virus Kit Cat. No. 60704
Hazard: Certain lots of the QIAamp DSP Virus Kit, REF 60704, used in analytic workflows could result in decreased performance.