Recall Z-1517-2014— Siemens Healthcare Diagnostics

Name: FDA recall Z-1517-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-20

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, initiated 2013-12-20, terminated 2018-05-18. It names 2 FDA 510(k) clearances: K960067, K931703. Product: 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.. Reason: Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays..

Recalling firm: Siemens Healthcare Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2013-12-20
Terminated: 2018-05-18
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

2 on FDA's record

K960067 — IMMILITE TOTAL IGEDiagnostic Products Corp.·cleared 1996-02-14
K931703 — IMMULITE TOTAL IGEDiagnostic Products Corp.·cleared 1993-08-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.