EZ2 Connect MDx 9003230Recalls & reported problems
QIAGEN GmbH · The EZ2 Connect MDx is a compact benchtop instrument for automated isolation of nucleic acids from up to 24 samples in parallel, using sealed prefilled cartridges The EZ2 Connect MDx system is designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. The EZ2 Connect MDx is intended to be used only in combination with QIAGEN kits indicated for use with the EZ2 Connect MDx instrument for the applications described in the kit handbooks. The EZ2 Connect MDx system is intended for use by professional operators, such as technicians and physicians trained in molecular biological techniques and the operation of the EZ2 Connect MDx system. · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- 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, 1 still open.
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
- Mar 4, 2024Open, Classified
Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost
Z-1508-2024 · 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
- BD MAX™ ExK™ DNA-2 442819Becton, Dickinson And Company · CLINICAL SAMPLE CONCENTRATOR1 recall0 reports
- EZ1 DSP Virus Kit 4QIAGEN GmbH · 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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