Alinity m 09N26-010Recalls & reported problems
Abbott Molecular Inc. · Alinity m Integrated Reaction Units · Class 2
All models of Alinity m (13)
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
- Feb 11, 2022Terminated
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
Z-0710-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other real time Nucleic acid amplification system devices
- BD MAX™ System 441916Becton, Dickinson And Company · real time Nucleic acid amplification system2 recalls1,109 reports
- Alinity m 08N53-002Abbott Molecular Inc. · real time Nucleic acid amplification system4 recalls950 reports
- BD PCR Cartridge 437519Becton, Dickinson And Company · real time Nucleic acid amplification system1 recall140 reports
- BD MAX™ Enteric Viral Panel 443985Becton, Dickinson And Company · real time Nucleic acid amplification system1 recall135 reports
- Verigene® Processor SP 10-0000-07Nanosphere, Inc. · Real Time Nucleic Acid Amplification System3 recalls0 reports
- BD MAX™ StaphSR 443419Becton, Dickinson And Company · real time Nucleic acid amplification system2 recalls1 death44 reports
- Revogene 610210Meridian Bioscience, Inc. · Real Time Nucleic Acid Amplification System2 recalls10 reports
- FilmArray® BCID Panel RFIT-ASY-0126Biofire Diagnostics, LLC · Real Time Nucleic Acid Amplification System2 recalls2 deaths4 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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