Immulite System- IGF-1 (Insulin like Growth Hormone) - 1000 and 2000 Assay (2017-11-30)
- Starting date:
- November 30, 2017
- Posting date:
- January 8, 2018
- 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-65590
Affected Products
A. Immulite 2000 System- IGF-1 (Insulin Like Growth Hormone) Assay
B. Immulite System- IGF-1 (Insulin Like Growth Hormone) Assay
C. Immulite 1000 System- IGF-1 Assay
Reason
In response to customer feedback, Siemens evaluated alternate statistical methods to determine if an alternate method would be a better fit for the reference range data published in the Information for Use (IFU). Our investigation concluded that the LMS method provided a better fit to the data and produced ranges more consistent with the expected physiological change in IGF-I levels compared to use of the weighted average results reported in the IFU.
Affected products
A. Immulite 2000 System - IGF-1 (Insulin like Growth Hormone) Assay
Lot or serial number
Not applicable
Model or catalog number
L2KIGF2
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
B. Immulite System - IGF-1 (Insulin like Growth Hormone) Assay
Lot or serial number
Not applicable
Model or catalog number
LKIGF1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
C. Immulite 1000 System - IGF-1 Assay
Lot or serial number
Not applicable
Model or catalog number
LKIGF1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM