Olympus AU600 Clinical Chemistry Analyzer

• • Completed Z-1908-2025 FDA Class II ·initiated 30 Apr 2025

  Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration being dispensed, which may not be detectable by QC checks, which could lead to the reporting of false low test results (Max 34% error at 1.0 microliters and 7% error at 1.6 microliters sample dispensing volume), which may lead to delayed recognition and treatment.

• • Terminated Z-1704-2017 FDA Class II ·initiated 13 Feb 2017

  Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match.

• • Terminated Z-2309-2016 FDA Class II ·initiated 30 Jul 2015

  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.

• 2 recalls, same reason

  • Terminated Z-0153-2014 FDA Class II ·initiated 9 Sep 2013
  • Terminated Z-0152-2014 FDA Class II ·initiated 9 Sep 2013

  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.

• 2 recalls, same reason

  • Terminated Z-0974-2012 FDA Unclassified (pre-2012) ·initiated 12 Jul 2010
  • Terminated Z-0975-2012 FDA Unclassified (pre-2012) ·initiated 12 Jul 2010

  The recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow.

510(k) Number

K961274 ↗

FDA Product Code

JJE

Device Class

Class I

Regulation

21 CFR Part 862.2160

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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