Roche Elecsys 1010
Roche · Model Elecsys 1010
• Innovative bar coding system for reagents • Liquid level and clot detection • Bi-directional interfacing • Calibrators and controls offering large data capacity • Refurbished with 90 day parts warranty • Reagents, controls, and consumables may be available • Service contracts may be available
Key tips
- ·When no category-specific guidance fits, default to the manufacturer's own service manual and the general troubleshooting method in the Engineer's Guide.
- ·Run an incoming and annual electrical safety test regardless of how niche the device is.
Typical Failure Modes
Failure patterns typical of this equipment class - general BMET reference, not verified against this exact unit's own service history unless flagged. Severity is a category-level estimate.
Calibration drift
HighSymptoms: Readings out of tolerance on verification check.
Root cause: Reference component aging.
Battery / power fault
MediumSymptoms: Won't power on, unexpected shutdown mid-test.
Root cause: Aged internal battery or PSU.
Test lead / connector wear
MediumSymptoms: Intermittent or no reading through a specific lead.
Root cause: Repeated connect/disconnect cycles.
Display / readout fault
LowSymptoms: Blank, frozen, or garbled display.
Root cause: Display module or driver board aging.
Serviceable Parts & Consumables
The parts a BMET typically services on this class of equipment. Service class and relative cost are general engineering estimates for the category, not figures from this unit's documentation. Part numbers appear only when pulled from this unit's own service manual. Always confirm intervals and pricing against the manufacturer.
Display module
Class Major service partRel. cost $$$R&R Difficult
Calibration reference module
Send out for annual re-certification.
Class Major service partRel. cost $$$$R&R Difficult
Rechargeable battery pack
Class Periodic replacementRel. cost $$R&R Fairly easy
Test lead set
High-turnover; keep spares.
Class Periodic replacementRel. cost $$R&R Easy
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Display module | Major service part | $$$ | Difficult |
| Calibration reference module Send out for annual re-certification. | Major service part | $$$$ | Difficult |
| Rechargeable battery pack | Periodic replacement | $$ | Fairly easy |
| Test lead set High-turnover; keep spares. | Periodic replacement | $$ | Easy |
Relative cost: $ lowest · $$$$ 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.
- ·Follow the manufacturer's PM schedule
- ·Perform incoming and annual electrical safety testing per facility biomedical program
Troubleshooting Approach
A structured starting point derived from the failure modes above. Follow the manufacturer's service documentation for the actual procedure.
Symptom: Calibration drift
- Confirm the presentation - typically readings out of tolerance on verification check - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: reference component aging.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the calibration reference module per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Symptom: Battery / power fault
- Confirm the presentation - typically won't power on, unexpected shutdown mid-test - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: aged internal battery or PSU.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the rechargeable battery pack per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Varies by device - check the unit's own manual for facility placement guidance
Documents & Manuals
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
Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.
- 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
Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Discrepant result reporting may result.
- 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
A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.
- 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
Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not be used when monitoring patient being treated with fulvestrant. Customers should be informed that fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug. If treatment with fulvestrant has been altered or discontinued as a result of falsely elevated e
- RECALL
Roche Diagnostics internal investigations in R&D have shown that the claims for biotin interference and the sample stability given in the Elecsys -CrossLaps (-CL) assay package insert version 5, could not be reproduced. The -CrossLaps test results contribute to the monitoring of antiresorptive therapy. False low or false normal results may lead to delayed diagnosis and treatment of osteoporosi
- 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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