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Immulite System-Rubella Quantitative IGG Assay
- Starting date:
- November 15, 2016
- Posting date:
- December 5, 2016
- 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-61288
Reason
Siemens Healthcare Diagnostics has observed that the Immulite Systems Rubella Quantitative IGG Calibration Verification Material Level CVM4 (LRUBCVM4) is recovering high outside of the published instructions for use (IFU) guideline. The maximum individual replicate observed internally by Siemens for LRUBCVM4 using Lot 0101 and 0102 was 687 IU/mL, which is above the provided IFU guideline range of 352 - 528 IU/mL.
Affected products
Recalls and Safety Alerts - Management System
Immulite System-Rubella Quantitative IGG Assay
Lot or serial number
0101
0102
Model or catalog number
LRUBCVM
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM