FDA-Device2014-05-07Class II
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.
Siemens Healthcare Diagnostics
Hazard
Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.
Sold states
Worldwide distribution.
Affected count
18,489 units
Manufactured in
511 Benedict Ave, Tarrytown, NY, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1518-2014Don't want to check this manually?
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