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IMMULITE C-PEPTIDE SYSTEM ASSAYS (2015-08-19)
- Starting date:
- August 19, 2015
- Posting date:
- September 1, 2015
- 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-54876
Affected Products
- IMMULITE SYSTEM C-PEPTIDE ASSAY
- IMMULITE 1000 SYSTEM - C-PEPTIDE ASSAY
Reason
Manufacturer has confirmed the potential for over-recovery of the c-peptide CVM top level with CVM lots 012 (level j) and 0101 (level 4) when used with the Immulite Systems C-Peptide Assays. in some instances this may lead to results outside the range published in the CVM instructions for use (IFU). Internal testing demonstrated that all other levels for CVM lots 012 and 0101 are unaffected. The potential over-recovery is limited to the top level CVM and patient results are not impacted.
Affected products
A. IMMULITE SYSTEM C-PEPTIDE ASSAY
Lot or serial number
0101
Model or catalog number
LPEPCVM
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
B. IMMULITE 1000 SYSTEM - C-PEPTIDE ASSAY
Lot or serial number
0101
Model or catalog number
LPEPCVM
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM