Olympus AU5400 Clinical Chemistry Analyzer

• • Terminated Z-0152-2014 FDA Class II ·initiated 9 Sep 2013 ·on shared 510(k) K011720

  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.

• • Terminated Z-1430-2013 FDA Class II ·initiated 26 Apr 2013 ·on shared 510(k) K011720

  Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated detergent. Beckman Coulter has received complaints that the joint connecting the tubing appears to disintegrate over time, causing a leak.

• 2 recalls, same reason

  • Terminated Z-0974-2012 FDA Unclassified (pre-2012) ·initiated 12 Jul 2010 ·on shared 510(k) K011720
  • Terminated Z-0977-2012 FDA Unclassified (pre-2012) ·initiated 12 Jul 2010 ·on shared 510(k) K011720

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

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K011720 ↗

FDA Product Code

CIX

Device Class

Class II

Regulation

21 CFR Part 862.1035

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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