Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE Recalled by Siemens Healthcare Diagnostics Due to Siemens confirmed an overall average positive bias of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics directly.
Affected Products
IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, 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.
Quantity: 18,489 units
Why Was This Recalled?
Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.
Where Was This Sold?
Worldwide distribution.
About Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics has 27 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report