Immulite 2500 Automated Immunoassay Analyzer

• • Terminated Z-1033-2010 FDA Unclassified (pre-2012) ·initiated 21 Oct 2009 ·on shared 510(k) K033234

  The recall was initiated because Siemens Healthcare Diagnostics has identified there is the potential for patient results to be biased low (-0.3 Sample to Cutoff [S/CO] ratio units) due to incompatibility of the Toxoplasma IgM kits with this particular lot of IgG/IgM Sample Diluent. All available lots of the IMMULITE 2000/2500 Toxoplasma IgM kits (L2KTM/L5KTM) are incompatible with Diluent lot 150

• • Terminated Z-1399-2009 FDA Unclassified (pre-2012) ·initiated 5 Jan 2009 ·on shared 510(k) K033234

  Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper.

• • Terminated Z-0263-05 FDA Unclassified (pre-2012) ·initiated 29 Oct 2004

  Erroneous handling of samples will cause problems after the system is placed in 'Sample-pause'.

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

510(k) Number

K033234 ↗

FDA Product Code

DHA

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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