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Immulite Products
- Starting date:
- October 10, 2012
- Posting date:
- October 29, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15174
Recalled Products:
- Immulite 2000 / 2000 XPI, IGF-1 Assay
- Immulite System, IGF-1 Assay
- Immulite 1000, IGF-1 Assay
Reason
Siemens has confirmed a negative bias against mean values obtained with the LGCOCM Control lot 0026 level 2 when used with Immulite/Immulite 1000 IGF-1 (LGKF1) kit lots 322 and above. Also confirmed is an increase of mean values obtained with the LGCOCM control lots 0025, 025l, and 0026 when used with Immulite 2000 / Immulite 2000 XPI IGF-1 (L2KGF2) kit lots 486 and 487.
Affected products
A. Immulite 2000 / 2000 XPI, IGF-1 Assay
Lot or serial number
'025L
Model or catalog number
LGCOCM
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Products Limited
B. Immulite System, IGF-1 Assay
Lot or serial number
'0025
Model or catalog number
LGCOCM
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Products Limited
C. Immulite 1000, IGF-1 Assay
Lot or serial number
'0026
Model or catalog number
LGCOCM
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Products Limited