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Recall Observatory FDA recall evidence

Device product

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

Z-2290-2020

April 08, 2020

Class II

Product summary

Firm
Qiagen Sciences LLC
Event
Event 85565
Status
Terminated
Classification
Class II
Quantity
530 kits within expiry
Official record key
device-enforcement:Z-2290-2020

Official wording

Reason: 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.

Code information: All lots

Distribution pattern: US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.