Afinion™ 2
Abbott Diagnostics Technologies AS · Model 1116986
Afinion 2 is a compact, fully automated, multi-assay analyzer for professional near-patient testing and laboratory use. Afinion 2 is designed for use with the Afinion Test Cartridges only. The Afinion 2 System, consisting of Afinion 2 Analyzer with Afinion Test Cartridges and Afinion Controls, is intended for in vitro diagnostic use only. Contents: 1 Afinion 2 Analyzer.
Intended use: A portable, electrically-powered instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technology(ies) [e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence]. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.
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.
Result / QC failure
HighSymptoms: Result flagged or biased, QC control out of range, strip / cartridge error code.
Root cause: Expired or mishandled strips / cartridges, a temperature / hematocrit interference, or an optics / electrode fault.
Strip / cartridge port fault
MediumSymptoms: Strip not detected, error on insertion, intermittent contact.
Root cause: Contaminated or worn strip-port contacts / optics.
Will not power on / battery fault
MediumSymptoms: Dead unit, short battery life, will not charge.
Root cause: Depleted or aged battery.
Barcode / connectivity fault
LowSymptoms: Operator / lot barcode will not scan, results not sent to the docking / LIS.
Root cause: Barcode reader or the docking-station / wireless link.
Display / button fault
LowSymptoms: Missing segments, unresponsive buttons.
Root cause: Display or keypad 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.
Test strips / cartridges
Class Frequent wear itemRel. cost $$R&R Easy
QC control solutions
Class Frequent wear itemRel. cost $R&R Easy
Battery
Class Frequent wear itemRel. cost $R&R Easy
Strip-port contacts / optics module
Class Periodic replacementRel. cost $$R&R Moderate
Docking station / barcode reader
Class Periodic replacementRel. cost $$R&R Fairly easy
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Test strips / cartridges | Frequent wear item | $$ | Easy |
| QC control solutions | Frequent wear item | $ | Easy |
| Battery | Frequent wear item | $ | Easy |
| Strip-port contacts / optics module | Periodic replacement | $$ | Moderate |
| Docking station / barcode reader | Periodic replacement | $$ | Fairly 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.
- ·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: Result or QC failure
- Repeat with a fresh strip / cartridge from a correctly stored, in-date vial.
- Run the QC control solutions at each level.
- Confirm the meter is coded / calibrated to the current strip lot.
- Clean the strip port per the manual.
- Quarantine the strip lot if QC fails; replace the meter if QC still fails with good strips.
Symptom: Strip not detected
- Inspect and clean the strip-port contacts / optics.
- Try several strips from a fresh vial.
- Check for physical damage to the port.
- Replace the battery.
- Replace the meter if it will not read good strips.
Technical Specs
- Handling Environment Temperature
- 15°C to 32°C
- Storage Environment Humidity
- 10 Percent (%) Relative Humidity to 95 Percent (%) Relative Humidity
- Storage Environment Temperature
- -29°C to 60°C
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- No
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Multiple clinical chemistry analyser IVD, point-of-care
- FDA product classification
- Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
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
Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.
- RECALL
The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional.
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