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Immulite 2000 System - Total IgE Assay (2013-12-27)
- Starting date:
- December 27, 2013
- Posting date:
- February 11, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-37875
Recalled products
- Immulite 2000 System - Total IgE Assay
Reason
Siemens Healthcare Diagnostics has confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the Immulite Systems Total LGE assays. The Immulite Total LGE controls (IECA1,2) will not detect the bias.
Affected products
A. Immulite 2000 System - Total IgE Assay
Lot or serial number
- Lots 260 and above
Model or catalog number
- L2KIE2
- L2KIE6
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM