
Iris Diagnostics · Model AUTION Max AX-4280
Easy-to-load strips require no calibration User-friendly interface, along with easy-to-load test strips that do not require calibration, result in rapid operator proficiency Minimal maintenance - less than five minutes per day - minimizes downtime AUTION dry pad urine test strips feature high sensitivity and specificity for accurate results and increased confidence Color compensation pad improves accuracy for urine chemistry Abnormal color detection notifies user of potential false positive reactions for urine chemistry Uninterrupted operation means operators can simply load the rack, press "Start" and walk away Increased walk-away capabilities allow flexible loading of up to 400 strips, combined with high-capacity throughput of up to 225 tests per hour Continuous loading of 100 samples and STAT features support laboratory efficiency goals.
Compiled for this model from its own documentation and established engineering knowledge for this equipment class - not from a verified service record. Confirm against the manufacturer's service manual.
Symptoms: Strip results flagged or biased, QC out of range, colour blocks misread.
Root cause: Expired or mishandled strips, a dirty / aged optics head, or a calibration issue.
Symptoms: Strip not transported, jams, or read at the wrong position.
Root cause: Worn strip-transport belt / tray or a position-sensor fault.
Symptoms: Repeated optics errors, non-uniform reads across the pads.
Root cause: Contaminated or aged reflectance LEDs / optics.
Symptoms: Poor particle images, flow-cell or camera errors.
Root cause: Flow-cell contamination, a pump fault, or the camera / focus.
Symptoms: No printout, results not sent to the LIS.
Root cause: Printer or the interface configuration.
Serviceable items for this model, compiled from its documentation and engineering knowledge for this equipment class. Service class and relative cost are estimates, not manufacturer figures; no part numbers are given. Confirm intervals and pricing against the manufacturer.
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Strip transport belt / tray | Periodic replacement | $$ | Moderate |
| Optics / reflectance head | Major service part | $$ | Moderate |
| Calibration strips / QC | Frequent wear item | $ | Easy |
| Sediment flow cell / pump tubing (if fitted) | Frequent wear item | $$ | Moderate |
| Printer / paper | Periodic replacement | $ | Fairly easy |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
A starting sequence for this model, compiled from its documentation and engineering knowledge for this equipment class. Follow the manufacturer's service documentation for the actual procedure.
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
No documents available for this device yet.
Synced live from the FDA openFDA API.
The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. This results in the instrument not passing controls and the customer not being able to run patient samples.
The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control, 101131-12, where the nitrite results read negative for the part B control, which should be positive.
Describe a symptom or error code. Bio answers from this device's own documented error codes, failure modes, parts, and guides.
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