
Instrumentation Laboratory · Model ACL 7000
Autodilution Random programming Optional external Data Management System (DMS) On-board barcode reader Alphanumeric keypad Cumulative and sample reports can be generated using an optional external printer.
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.
Symptoms: Flagged or implausible CBC counts, voteouts, clog alarms, poor precision.
Root cause: Debris or a clot partially blocking a counting aperture or the flow cell.
Symptoms: Short samples, aspiration errors, cap-piercing failures, carryover.
Root cause: Worn or bent sample probe / closed-vial piercer, or a worn shear / segment valve.
Symptoms: WBC, HGB or diff results shifted, high background, reagent alarms.
Root cause: Reagent depleted or wrong lot, or a pinch-valve / tubing fault.
Symptoms: Diff scattergrams abnormal, missing populations, flow-cell or laser alarm.
Root cause: Contaminated or aged flow cell, or the laser / optics.
Symptoms: Multiple parameter errors, priming failures.
Root cause: Pump or regulator drift.
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.
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Sample probe / closed-vial piercer | Periodic replacement | $$ | Moderate |
| Shear / segment valve | Periodic replacement | $$$ | Difficult |
| Pinch-valve / peristaltic tubing | Frequent wear item | $ | Moderate |
| Flow cell | Periodic replacement | $$$ | Difficult |
| System reagents / controls | Consumable | $$ | Easy |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
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.
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.
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
No documents available for this device yet.
Synced live from the FDA openFDA API.
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine), specific to instrument models that utilize a single reagent probe
Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
There is a potential for increased imprecision, out of range quality controls and prolonged sample results.
Potential for sample misidentification.
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
Sporadically lowered APTT results were observed with the PT/APTT Test Groups.
Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves
ACL TOP unit, when in emergency stop may release liquid during recovery sequence and contaminate sample tube.
Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy
Software may cause instrument to omit step causing reagent carrover which may effect patient test result
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