FDA Device recall Z-2290-2020
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
- FDA Device
- Class II
- terminated
- Published 2020-06-17
On 2020-06-17 the FDA classified a Class II recall of therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121 by Qiagen Sciences, citing 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 a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2290-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-08 |
| Published | 2020-06-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Qiagen Sciences |
| Distribution | US |
Product
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
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.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2290-2020%22
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