Roche Elecsys 2010
Roche · Model Elecsys 2010
Touch screen Easy to use software Two-dimensional barcode technology for reagents Calibrators and controls Ready-to-use reagents Refurbished with 90 day parts warranty Reagents, controls, and consumables may be available.
Key tips
- ·Run QC controls before trusting any repair - an analyzer that passes self-test can still report clinically wrong results.
- ·Rule out a reagent lot change before opening the instrument - it can look exactly like a hardware fault.
- ·Centrifuge rotors have a hard retirement age/cycle limit regardless of visible condition - don't eyeball it.
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.
- ·Daily QC controls run and reviewed
- ·Calibration verification per assay
- ·Routine cleaning and decontamination
- ·Scheduled reagent-path and pump-tubing maintenance
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.
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Central / core laboratory
- Point-of-care testing stations
- Blood bank
- Microbiology lab
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
- RECALL
Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed.
- RECALL
The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9 reagent, which may affect clinical interpretation.
- RECALL
Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area setting, (1.0 1.00) instead of (0.90 1.10).
- RECALL
Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.
- RECALL
The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a consequence, vitamin D deficiency may develop over time.
- RECALL
Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers.
- RECALL
e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays
- RECALL
An investigation has confirmed a considerably reduced recovery of Li-heparin plasma samples for Troponin I lot 163176 and Troponin I STAT lot 163177. In the worst case, Li-Heparin sample recovery may be as low as 50% of the serum recovery. Correct serum recovery has been confirmed for the affected lots. The issue is caused by the raw material lot (Poly-L-Lysin) instability. Poly-L-Lysin is the
- RECALL
Elecsys 2010 customers have reported getting no value and flag 48 results below expected value range after performing automatic dilution for a sample that previously recovered above the measuring range. Incorrect but believable results may occur for the CEA, Rubella IgG or SHBG assays. The other affected assays will generate either no value or a negative result, both of which are not bel
- RECALL
The test is not as sensitive, or as precise between runs, as claimed in the labeling. Low concentrations are observed only in saliva samples.
- RECALL
Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism.
- RECALL
Gel-like particle formation; may result in a clot settling in the analyzer measuring cell, which will create a low signal and may cause incorrectly high or low QC and/or patient results depending on the assay method.
- RECALL
A false negative result may be reported.
- RECALL
There is the possibility of high results with sera expected to have non-detectable levels of tPSA if these reagent lots are used in combination on the Modular Analytics E170 analyzer.
- RECALL
Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.
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