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Immulite Systems
- Starting date:
- November 16, 2012
- Posting date:
- December 24, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-25879
Recalled Products
- Immulite 2000 System IGF-1 (Insulin-like Growth Hormone) Assay
- Immulite System IGF-1 (Insulin-like Growth Hormone) Assay
- Immulite 1000 System IGF-1 Assay
Reason
There is a positive shift in patient medians of approximately 20% with the igf-I assay. An initial positive shift of approximately 15% occurred with immulite 2000/immulite 2000 xpi kit lot 441 (released december 2009), and in mid-2011 an additional positive shift of approximately 5% was observed with immulite 2000/immulite 2000 xpi kit lot 469 (released july 2011), leading to the total positive shift of approximately 20%.
Affected products
A. Immulite 2000 System IGF-1 (Insulin-like Growth Hormone) Assay
Lot or serial number
Lot 441 to 492
Model or catalog number
L2KGF2
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Products Limited
B. Immulite System IGF-1 (Insulin-like Growth Hormone) Assay
Lot or serial number
Lot 315 to 335
Model or catalog number
LKGF1
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Products Limited
C. Immulite 1000 System IGF-1 Assay
Lot or serial number
Lot 315 to 335
Model or catalog number
LKGF1
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Products Limited