HemoCue® Glucose 201 Analyzer
Hemocue AB · Model 120706
HemoCue Glucose 201 Analyzer mg/dL plasma
Intended use: A collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
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
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.
Centrifuge imbalance / bearing
HighSymptoms: Vibration, loud noise, stop error.
Root cause: Worn bearing or unbalanced rotor.
Reagent / wash flow fault
MediumSymptoms: Clogs, high blank, QC fail.
Root cause: Pump tube wear, air in line.
Temperature control fault
MediumSymptoms: Incubator out of range.
Root cause: Failed heater/fan or sensor.
Optics / lamp degradation
LowSymptoms: Low signal, wavelength drift.
Root cause: Lamp/LED or monochromator 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.
Incubator heater / fan
Class Periodic replacementRel. cost $$R&R Moderate
Sample aspiration probe
Frequent R&R on high-throughput analyzers.
Class Periodic replacementRel. cost $$$R&R Moderate
Peristaltic pump tubing
Consumable, replace proactively.
Class Frequent wear itemRel. cost $R&R Easy
Xenon / LED light source
Class Periodic replacementRel. cost $$$R&R Moderate
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Incubator heater / fan | Periodic replacement | $$ | Moderate |
| Sample aspiration probe Frequent R&R on high-throughput analyzers. | Periodic replacement | $$$ | Moderate |
| Peristaltic pump tubing Consumable, replace proactively. | Frequent wear item | $ | Easy |
| Xenon / LED light source | Periodic replacement | $$$ | Moderate |
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 structured starting point derived from the failure modes above. Follow the manufacturer's service documentation for the actual procedure.
Symptom: Sample probe / pipette clog
- Confirm the presentation - typically aspiration error, short sample, carryover - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: clot/crystal obstruction.
- 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 sample aspiration probe 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: Reagent / wash flow fault
- Confirm the presentation - typically clogs, high blank, QC fail - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: pump tube wear, air in line.
- 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 peristaltic pump tubing 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.
Technical Specs
- Storage Environment Temperature
- 0°C to 50°C
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- No
- Prescription use
- Rx only
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Glucose monitoring system IVD, point-of-care
- FDA product classification
- Glucose Oxidase, Glucose
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
Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency, and purity of the product. This failure could increase the probability of an incorrect test result or a delayed test result.
- RECALL
During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.
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