EZ1 DSP Virus Kit 4Recalls & reported problems
QIAGEN GmbH · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- May 28, 2018Terminated
Underfilled reagent well that could lead to incorrect results
Z-2596-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
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- BD MAX™ ExK™ DNA-1 442817Becton, Dickinson And Company · CLINICAL SAMPLE CONCENTRATOR1 recall4 reports
- BD MAX™ ExK™ TNA-2 442825Becton, Dickinson And Company · CLINICAL SAMPLE CONCENTRATOR1 recall0 reports
- EZ2 Connect MDx 9003230QIAGEN GmbH · Clinical Sample Concentrator1 recall0 reports
- BD MAX™ ExK™ DNA-2 442819Becton, Dickinson And Company · CLINICAL SAMPLE CONCENTRATOR1 recall0 reports
- xTAG® RVP (Respiratory Viral Panel) I019C0111Luminex Molecular Diagnostics, Inc · CLINICAL SAMPLE CONCENTRATOR1 recall0 reports
- m2000 09K14-02Abbott Molecular Inc. · CLINICAL SAMPLE CONCENTRATOR23 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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