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Qiagen Sciences LLC recalls therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Recalled June 17, 2020 · FDA recall Z-2290-2020 · Qiagen Sciences
Hazard
There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In these rare cases, the controls pass correctly, while a fluorescence artefact in the mutation assay causes an incorrect valid mutation positive result. · FDA Class II
Units
530 kits within expiry
Sold at
US Nationwide.
Description
There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In these rare cases, the controls pass correctly, while a fluorescence artefact in the mutation assay causes an incorrect valid mutation positive result.
Product
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Manufacturer(s)
Qiagen Sciences LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →