Siemens Healthcare Diagnostics: Medical Device Recall in 2014 - (Recall #: Z-1517-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum.

Product Classification:

Class II

Date Initiated: December 20, 2013

Date Posted: May 7, 2014

Recall Number: Z-1517-2014

Event ID: 67210

Reason for Recall:

Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.

Status: Terminated

Product Quantity: 5953 units

Code Information:

Lots 326 through 333

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated