CLASS II Device recall · Reported 17 Jun 2020 · FDA Enforcement Report
therascreen EGFR RGQ PCR Kit , Reference Number recalled
Qiagen Sciences is recalling therascreen EGFR RGQ PCR Kit , Reference Number, distributed nationwide in the US. The recall was initiated on 8 Apr 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2290-2020
- FDA event ID
- 85565
- Recalling firm
- Qiagen Sciences, Germantown, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Apr 2020
- FDA classified
- 5 Jun 2020
- Reported
- 17 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 8 Apr 2020 | Recall initiated by company | |
| 5 Jun 2020 | Classified by FDA | +58 days |
| 17 Jun 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
All lots
Where was it sold?
US Nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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