Immulite Rubella Igm, LKRM1, LKRM2, Immulite 2000 Rubella Igm, Model L2KRM2, L2KRM6

• 2 recalls, same reason

  • Terminated Z-0081-2017 FDA Class II ·initiated 24 Aug 2016
  • Terminated Z-0082-2017 FDA Class II ·initiated 24 Aug 2016

  Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the IMMMULITE 2000/IMMULITE 2000 XPi platforms.

510(k) Number

K012077 ↗

FDA Product Code

LFX

Device Class

Class II

Regulation

21 CFR Part 866.3510

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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