Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2290-2020 — therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121

U.S. FDA — Device Enforcement · United States · 2020-04-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2290-2020
Date of alert
2020-04-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Qiagen Sciences LLC
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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