4 results
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18ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223
FDA Recall
Open, Classified
·Qiagen GmbH Qiagen Str. 1 Hilden Germany·Product code QLT·May 19, 2023
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
QIAstat-Dx Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae REF 691223
FDA Recall
Open, Classified
·Qiagen GmbH Qiagen Str. 1 Hilden Germany·Product code QJR·May 9, 2023
QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214
FDA Recall
Open, Classified
·Qiagen GmbH Qiagen Str. 1 Hilden Germany·Product code QLT·May 19, 2023