Ortho Clinical Diagnostics VITROS 350
Ortho Clinical Diagnostics · Model VITROS 350
The VITROS 350 doesn’t require highly-trained operators - simple procedures allow around-the-clock availability to all members of the lab staff Easy to train and cross train operators Walk-away operation Quality control procedures are required just once each day and calibration intervals up to 6 months Ergonomically designed, flat low-glare LCD touch screen monitor Keyboard platform and support arm Flexible, customized positioning On-board documentation and help function Up to 300 results per hour On-board capacity for all 45 assays Primary tube sampling On-board dilution Flexible processing for manual, stat or automated testing Unique sample processing capabilities like disposable tips, bubble and clot detection assure confidence in results Self-monitoring alerts operators to prompt action, avoiding testing delays No plumbing, drains, vents, deionized water is required; all “waste” is contained in used test slides which are disposed daily
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.
Sample probe / pipette clog
MediumSymptoms: Aspiration error, short sample, carryover.
Root cause: Clot/crystal obstruction.
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.
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.
Peristaltic pump tubing
Consumable - replace proactively.
Class Frequent wear itemRel. cost $R&R Easy
Xenon / LED light source
Class Periodic replacementRel. cost $$$R&R Moderate
Centrifuge rotor & bearings
Class Major service partRel. cost $$$R&R Difficult
Incubator heater / fan
Class Periodic replacementRel. cost $$R&R Moderate
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Peristaltic pump tubing Consumable - replace proactively. | Frequent wear item | $ | Easy |
| Xenon / LED light source | Periodic replacement | $$$ | Moderate |
| Centrifuge rotor & bearings | Major service part | $$$ | Difficult |
| Incubator heater / fan | Periodic replacement | $$ | 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
- Sample Capacity
- 40 (4 trays of 10 samples)
- Throughput
- 3600 samples/hr
- Sample Types
- Serum, Plasma, Urine, CSF
- Sample Volume
- 5 to 11 µL
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
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
- RECALL
Potentially Biased Results using VITROS Chemistry Products GLU Slides
- RECALL
Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.
- RECALL
The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a triglyceride concentration 600mg/dL, however the current triglyceride interference claim states interference should not occur below 800mg/dL of triglyceride.
- RECALL
The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The measuring range (15-300 mmol/L) for urine samples when tested with the Cl- slide is not affected. The current Cl- LoQ is 5 mmol/L and the LoQ determined by this investigation is 15 mmol/L.
- RECALL
The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for serum and urine samples and therefore affecting the low end of the measuring range for this assay. The current low end measuring range is 0.05mg/dL for serum and 1.2mg/dL for urine. Based on the CREA testing results for the LoQ, the revised low end CREA measuring range is 0.15mg/dL for serum and 3.2mg/dL for urine.
- RECALL
There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ Slide cartridges warmed at room temperature and loaded onto the analyzer after using the minimum warm up requirements stated in the IFU. If Quality Control (QC) results are within acceptable limits, reported results are acceptable and were not affected by this issue.
- RECALL
Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays. Ortho also tested several compounds following industry standard CLSI EP7-A2 for potential interference on VITROS GLU Slides during validation testing for a proposed change and confirmed Dextran 40 and Glutathione may interfere with current VITROS GLU Slides.
- RECALL
The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954.
- RECALL
Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.
- RECALL
Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913. Some positively biased results were identified during testing of a different VITROS PHYT Slide lot; the affected slides were not released for distribution. Since Lot 2613-0150-4913 was manufactured in the same event, there is the potential for slides from this lot to also be affected.
- RECALL
The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403.
- RECALL
Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.
- RECALL
Ortho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing Cup Arrays utilized on VITROS 250 and VITROS 350 Chemistry Systems. Increase in Software error due to affected Mixing Cup Arrays.
- RECALL
While performing interval testing, Ortho Clinical Diagnostics (OCD) determined that a surfactant was unintentionally added to VITROS Chemistry Products K+ Slides during the manufacturing process.
- RECALL
Ortho Clinical Diagnostics revised the VITROS Chemistry Products DGXN Slides Instructions for Use (IFU) and removed heparin plasma as a recommended specimen type for VITROS DGXN Slides
- RECALL
Ortho Clinical Diagnostics received complaints of lower than expected results (< 6 U/L) for samples that were known to be outside of the measuring (reportable) range (> 1000 U/L) when using Calibration Diskette/Assay Data Diskette Data Release Version (DRV) 5653 through 5666 and VITROS Chemistry Products ALT Slides, Generation (GEN) 26 (Product Code 1655281).
- RECALL
Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in control fluid values when using various lots of VITROS Chemistry Products PHBR Slides (Phenobarbital) from Coating 0053.
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