Immulite 1000 Automated Immunoassay Analyzer

• 2 recalls, same reason

  • Terminated Z-1701-2012 FDA Not yet classified ·initiated 30 Apr 2012 ·via K022603, on the same 510(k)
  • Terminated Z-1700-2012 FDA Not yet classified ·initiated 30 Apr 2012 ·via K022603, on the same 510(k)

  Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K022603 ↗

FDA Product Code

CEW

Device Class

Class II

Regulation

21 CFR Part 862.1545

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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