Immulite Ck-Mb, Model LKMB1 (100 Tests), LKMB5 (500 Tests); Immulite 2000 Ck-Mb, Model L2KMB2 (200 Tests), L2KMB6 (600)

• 2 recalls, same reason

  • Terminated Z-1271-2012 FDA Not yet classified ·initiated 25 Jan 2012
  • Terminated Z-1273-2012 FDA Not yet classified ·initiated 25 Jan 2012

  Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructions for Use (IFU). This difference applies to all IMMULITE platforms.

510(k) Number

K004002 ↗

FDA Product Code

JHX

Models / Variants

Immulite Ck-Mb, Model LKMB1 (100 Tests), LKMB5 (500 Tests)

Immulite 2000 Ck-Mb, Model L2KMB2 (200 Tests), L2KMB6 (600)

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K974842 Active Cleared 21 Apr 1998

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