Tosoh Bioscience G7 HPLC Analyzer
Tosoh Bioscience · Model G7 HPLC Analyzer
HbA1c and Β-thalassemia in one analyzer HbA1c results in 2.2 minutes NGSP certified Direct determination of stable HbA1c
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.
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
Analyzers were distributed with software which lacks a 510K
- RECALL
HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers should exercise caution when reviewing chromatograms and ensure that Flag 43 is enabled on their device to avoid reporting invalid test results in the presence of HbAE.
- RECALL
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
- RECALL
Power outages causes reporting software to shutdown.
- RECALL
The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negative bias occurs at the higher levels of HbA1c, e.g. 9%, but not at the diagnostic medical decision point of 6.5%.
- RECALL
The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015. The correct expiration date is October 2014.
- RECALL
The value after reconstitution appeared to be lower than the assigned value on the label. The measured value for Lot BCAL05R was 5.3%, whereas the value on the label is 5.7%. The criteria of the value is +/- 0.3%.
- RECALL
The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports HbF and HbA2 quantitative percentages in whole blood. The firm received complaints that the A2 peak could not be detected with the G7 Beta-thalessemia columns.
- RECALL
A software upgrade was released by the firm for its AIA-600 II analyzers, in that washing deficiencies caused by the analyzer were corrected.
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