Device product
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.
Z-1518-2014
Product summary
- Event
- Event 67210
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,489 units
- Official record key
device-enforcement:Z-1518-2014
Official wording
Reason: Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.
Code information: Lots 260 through 275
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.