therascreen EGFR RGQ PCR Kit — Class II medical device recall Z-2290-2020
Terminated recall by Qiagen Sciences LLC, reported 2020-06-17, distributed nationwide. There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In
| Recall number | Z-2290-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen Sciences LLC, Germantown, MD, United States |
| Recall initiated | 2020-04-08 |
| Classified | 2020-06-05 |
| Reported by FDA | 2020-06-17 |
| Terminated | 2021-06-03 |
| Distributed | Nationwide (US) |
| Quantity | 530 kits |
| Reason classes | potency |
| Model numbers | 870121 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2290-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.