Verigene® Processor SP 10-0000-07 (UDI 00857573006010)Recalls & reported problems
Nanosphere, Inc. · The Verigene® Processor SP is an instrument which integrates sample preparation, target amplification, and target hybridization within a single device as part of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. · Class 2
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
- 3
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
3 FDA recall records 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
- Oct 13, 2020Terminated
Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENESP devices.
Z-0476-2021 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Oct 13, 2020Terminated
Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENE SP devices.
Z-0477-2021 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Dec 10, 2018Open, Classified
No results/incorrect results due to failure of the hybridization heater.
Z-0054-2021 · Root cause: Component design/selection · Recall details · FDA record ↗
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- 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
- FilmArray® BCID Panel RFIT-ASY-0127Biofire Diagnostics, LLC · Real Time Nucleic Acid Amplification System2 recalls1 death1 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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