BECKMAN COULTER INC
AU5800 · Chemistry
510(k) Clearances (1)
Substantially Equivalent
Recalls (7)
Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match.
Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer, resulting in a short-circuit causing the instrument to go into a stop mode.
The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected.
The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyzers with the Automation Ready (AR) Sampler Kit. This software error results in the failure of the concentrated wash solution pump to stop, creating an overflow or leak on each analyzer unit.
Beckman Coulter, Inc. initiated this recall because there is a software error that has the potential to cause the reporting of erroneous patient results because of misidentification by the AU5800 system.
Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration (CAL) sample results are not saved and the software reverts to a previously stored, acceptable RB/CAL result.
Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling on the diluted detergent tank to show the proper disposition of the on/off valve.
MAUDE Adverse Events (10)
FDA Classification (67)
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry