Qiagen GmbH FDA Recalls

4 recalls on file across devices, 0 of them Class I and 4 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	Reason	Class	Initiated
therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection oClass IIAug 22, 2023Handbook Revision (Rev13) a dilution step is indicated as a	Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAIL	Class IIDevices	Aug 22, 2023
QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intendeClass IIMay 19, 2023Identified a decreased performance reliability rate, Run ab	Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample	Class IIDevices	May 19, 2023
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) sampleClass IIMay 19, 2023Identified a decreased performance reliability rate, Run ab	Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample	Class IIDevices	May 19, 2023
QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CClass IIMay 9, 2023If cartridges of the affected Serial numbers (SNs) are used,	If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY0	Class IIDevices	May 9, 2023