3 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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therascreen KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)
FDA Recall
Open, Classified
·Qiagen GmbH Qiagen Str. 1 Hilden Germany·Product code OWD·August 22, 2023
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
FDA Recall
Open, Classified
·Qiagen Sciences LLC·Product code OWD·February 25, 2022
therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)
FDA Recall
Open, Classified
·Qiagen Sciences LLC·Product code OWD·February 25, 2022