iChem Velocity Elite/Stand-Alone Velocity (NA)Recalls & reported problems
Beckman Coulter Ireland Inc. · "2.5 iChem Velocity Instrument Bring Up and Test; 800-7167 iChem VELOCITY Automated Urine Chemistry System w load/Unload (NA)" "2.5 iChem Velocity Instrument Bring Up and Test; 800-7719 Stand-Alone Velocity (NA)" · Class 1
All models of iChem Velocity (3)
Data updated Oct 18, 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 18, 2026.
Recalls naming this device
- Oct 28, 2019Class IITerminated
Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).
Z-0913-2020 · Root cause: Software in the Use Environment · Recall details · FDA record ↗
Other Automated Urinalysis System devices
- iQ200 Elite Plus (US) (2008 Version) (NA)Beckman Coulter Ireland Inc. · Automated Urinalysis System3 recalls2 reports
- iQ200 Sprint Pro (NA)/SPRINT w load/unload (NA)/SPRINT Pro w load/unload (NA)/Sprint PBeckman Coulter Ireland Inc. · Automated Urinalysis System3 recalls1 report
- iQ200 Select/Elite Pro (NA)Beckman Coulter Ireland Inc. · Automated Urinalysis System3 recalls0 reports
- iQ200 Select Plus Kit 2008 Analyzer (NA)/ Select Pro (NA)Beckman Coulter Ireland Inc. · Automated Urinalysis System2 recalls4 reports
- iChem Velocity Back-Integrated Velocity (NA)Beckman Coulter Ireland Inc. · Automated Urinalysis System1 recall15 reports
- Aution™ Hybrid AU-4050 Chemical Analyzer 14603Arkray USA, Inc. · Automated Urinalysis System1 recall4 reports
- UA Win10 Kit C52900Beckman Coulter Ireland Inc. · Automated Urinalysis System1 recall0 reports
- cobas u 411 Urine Analyzer 4906969001Roche Diagnostics GmbH · AUTOMATED URINALYSIS SYSTEM16 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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