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Immulite 2000 System - Osteocalcin Assay (2014-01-20)
- Starting date:
- January 20, 2014
- 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-37927
Recalled products
- Immulite 2000 System - Osteocalcin Assay
Reason
Siemens Healthcare Diagnostics has confirmed under recovery up to 50% in patient values with the Immulite 2000 / Immulite 2000 XPI Osteocalcin (l2KON2) kit lots 218, 219, 220 and 221. Quality control materials will not detect the bias.
Affected products
A. Immulite 2000 System - Osteocalcin Assay
Lot or serial number
- 218
- 219
- 220
- 221
Model or catalog number
- L2KON2
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM