Z-2290-2020 Class II Terminated
FDA device recall Z-2290-2020 was initiated by Qiagen Sciences LLC on April 8, 2020 and is designated Class II. Reason for recall: 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 mutati… The recall status is terminated (terminated June 3, 2021). Affected quantity: 530 kits within expiry.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2020
- Initiation Date
- April 8, 2020
- Termination Date
- June 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 530 kits within expiry
Product Description
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Reason for Recall
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.
Distribution Pattern
US Nationwide.
Code Information
All lots