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IMMULITE 2000 System - GI-MA ASSAY (2015-02-13)
- Starting date:
- February 13, 2015
- Posting date:
- March 5, 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-52445
Recalled Products
IMMULITE 2000 System - GI-MA ASSAY
Reason
Siemens Healthcare Diagnostics has confirmed a positive bias with the Bio-Rad Lyphochek tumor marker plus control and the Bio-Rad Liquichek tumor marker control when used with Immulite 2000/Immulite 2000 XPI GI-MA (CA19-9) assay kit Lots 312 and 313. In addition, a greater than expected change in patient sample recovery may be observed when moving from kit Lot 311 to kit Lots 312 and above. While recovery with patient samples for individual kit Lots continues to meet Siemens quality control release specification, kit Lot 311 was observed to perform at the lower end of the specification and kit Lot 312 at the upper end of the specification, resulting in a greater than expected difference between these two kit Lots.
Affected products
IMMULITE 2000 System - GI-MA ASSAY
Lot or serial number
LOTS 312 , 313
Model or catalog number
L2KGI2
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis