medical Class II Updated 2020-06-17

Qiagen Sciences LLC recalls therascreen EGFR RGQ PCR Kit (24), Reference Number REF 8701

Recalled Product

therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lots
View official government recall

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