QIAstat-Dx® Respiratory Panel Plus V1Recalls & reported problems
QIAGEN GmbH · Class 2
Data updated Oct 18, 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 18, 2026.
Recalls naming this device
- Mar 12, 2025Class IIOpen, Classified
Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
Z-1504-2025 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗
Other Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents devices
- BioFire® Respiratory Panel 2.1 423742Biofire Diagnostics, LLC · Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents3 recalls4 reports
- Panther Fusion® KIT, SARS/FLU A/B/RSV REAG CARTRDG, 96T, FUS, IVDHologic, Inc. · Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents1 recall7 reports
- DASH® SARS-CoV-2 & Flu A/B Test Kit SG-0006Nuclein, LLC · Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents1 recall0 reports
- BD Respiratory Viral Panel for BD MAX™ System 445373Becton, Dickinson And Company · Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents8 reports
- GeneXpert® XPRS4PLEX-10Cepheid · Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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