IMMUNOASSAY SPECIALITY I - LEVEL 2 (IA SPECIALITY I LEV 2)
RANDOX LABORATORIES LIMITED · Model IAS3114
This product is intended for in vitro diagnostic use, in the quality control of the accuracy of Immunoassays on clinical chemistry systems. This material can be used to monitor the control of accuracy or the control of reproducibility of immunoassays.
Intended use: A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.
Key tips
- ·A no-signal/flatline alarm gets checked on the patient first, not the monitor - rule out a real clinical event before troubleshooting.
- ·Recalibrate NIBP against a reference manometer, not just a self-test pass.
- ·Reused patient cables (SpO2, ECG leads) are a common source of intermittent-fault complaints - swap the cable before the module.
Typical Failure Modes
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.
QC / calibration failure on an assay
HighSymptoms: Controls out of range, calibration fails, flagged results on one or more assays.
Root cause: Reagent pack issue, a probe / dispense fault, incubation-temperature drift, or a detector / optics fault.
Sample / reagent probe or pipettor fault
MediumSymptoms: Short aspiration, no dispense, clot / level-sense errors, carryover.
Root cause: Clogged or bent probe, a syringe / pump fault, or a level-sense fault.
Wash / aspiration station fault
MediumSymptoms: High background / noise, poor precision, elevated blanks.
Root cause: Blocked wash-station nozzles or a wash-pump / vacuum fault.
Incubator temperature fault
MediumSymptoms: Assay drift or bias, incubation-temperature alarm.
Root cause: Incubator heater or temperature-sensor fault.
Detector / luminometer / photometer fault
MediumSymptoms: Low signal, high CV, detector-error message.
Root cause: PMT / detector ageing or an optics fault.
Serviceable Parts & Consumables
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.
Sample / reagent probe
Class Periodic replacementRel. cost $$R&R Moderate
Syringe / dispense pump
Class Periodic replacementRel. cost $$R&R Moderate
Wash-station nozzles / pump tubing
Class Frequent wear itemRel. cost $R&R Moderate
Incubator heater / temperature sensor
Class Major service partRel. cost $$R&R Moderate
Detector / PMT module
Class Major service partRel. cost $$$R&R Difficult
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Sample / reagent probe | Periodic replacement | $$ | Moderate |
| Syringe / dispense pump | Periodic replacement | $$ | Moderate |
| Wash-station nozzles / pump tubing | Frequent wear item | $ | Moderate |
| Incubator heater / temperature sensor | Major service part | $$ | Moderate |
| Detector / PMT module | Major service part | $$$ | Difficult |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
PM Checklist
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.
- ·Routine cable and lead-wire inspection for fraying/wear
- ·Battery conditioning cycle
- ·NIBP calibration check against a reference manometer
- ·ECG / SpO2 accuracy verification against a patient simulator
- ·Annual electrical safety test
Troubleshooting Approach
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.
Symptom: QC or calibration failure
- Run fresh controls and recalibrate the affected assay.
- Confirm the reagent pack is in date, mixed and correctly loaded.
- Clean the probes and wash stations.
- Check the incubator temperature against a reference.
- Escalate a detector / optics fault to the OEM.
Symptom: Probe or pipettor fault
- Inspect the probe for a bend or clog and clear it.
- Run the fluidics prime.
- Check the syringe / pump and tubing for leaks or air.
- Verify level sensing and probe position.
- Replace the probe or syringe as found and re-run QC.
Technical Specs
- Storage Environment Temperature
- 2°C to 8°C
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- Yes
- Prescription use
- Rx only
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Multiple-type clinical chemistry analyte profile IVD, control
- FDA product classification
- Multi-Analyte Controls, All Kinds (Assayed)
- Manufacturer support
- +442894451070 · technical.services@randox.com
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- ICU / CCU
- Emergency Department
- OR / PACU
- General med-surg floors
- Step-down units
- Telemetry units
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range
- RECALL
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
- RECALL
The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out of range could lead to a delay in reporting Troponin T results. If the failure occurs the operator may observe the quality control result for Troponin T falling outside range and/or increased imprecision for Quality Control monitoring.
- RECALL
An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for Randox Immunoturbidimetric and Siemens Centaur Classic methods and CKMB (-21% bias) for Roche e411, BioMerieux Vidas, and Siemens Centaur Classic methods.
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