Dimension Exl with Lm Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge, and Loci Thyroid Calibrator, Mod

• • Terminated Z-1615-2015 FDA Class II ·initiated 2 Apr 2015 ·on shared 510(k) K073604

  Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been installed with a non-standard instrument power plug.The use of a non-standard plug configuration as described may lead to a potential electrical hazard. The likelihood of potential clinical impact or injury due to this issue is extremely low.

• • Terminated Z-2133-2014 FDA Class III ·initiated 27 May 2014 ·on shared 510(k) K073604

  There is a misassembly issue with the photometer installed on Dimension Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a limited number of Dimension photometers were misassembled. These photometers are performing within specifications, but may lead to a shortened life of the source lamp.

• 3 recalls, same reason

  • Terminated Z-1048-2013 FDA Class III ·initiated 27 Feb 2013 ·on shared 510(k) K073604
  • Terminated Z-1046-2013 FDA Class III ·initiated 27 Feb 2013 ·on shared 510(k) K073604
  • Terminated Z-1047-2013 FDA Class III ·initiated 27 Feb 2013 ·on shared 510(k) K073604

  Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens h

• • Terminated Z-0458-2011 FDA Unclassified (pre-2012) ·initiated 12 Apr 2010

  Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaking cartridges may result in inaccurate test results.

• • Terminated Z-0581-2009 FDA Unclassified (pre-2012) ·initiated 30 Sep 2008 ·on shared 510(k) K073604

  Error messages, "Wash Aspirator Failure" and "Wash station unable to recover" are not generated when one or both HM wash probes are totally occluded.

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

510(k) Number

K073604 ↗

FDA Product Code

CEC

Device Class

Class II

Regulation

21 CFR Part 862.1695

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• Tgl Flex Reagent Cartridge

  Class I

  FDA 510(k) K010871 Active Cleared 9 Jul 2001

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