ARIES® System ARIES M12V1Recalls & reported problems
Luminex Corporation · The ARIES® System is a clinical multiplex test system that automates and integrates extraction of nucleic acid from a clinical sample, performs real -time PCR, and measuring and sorting multiple signals generated in an in vitro diagnostic assay. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records 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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jun 29, 2018Terminated
An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in sample/patient mismatch or duplicate results (from other patients specimens) for a patient order.
Z-2292-2019 · Root cause: Process control · FDA record ↗
- Apr 19, 2017Terminated
The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems populates patient sample IDs with a previously scanned sample ID when entering orders into an ARIES instrument.
Z-2094-2017 · Root cause: Nonconforming Material/Component · 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 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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