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MAS Cardioimmune XL
- Starting date:
- December 15, 2011
- Posting date:
- September 17, 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-25741
Recalled Products
- MAS Cardioimmune XL, Level L
- MAS Cardioimmune XL, Levels 1, 2, 3
- MAS Cardioimmune XL, Multi-Pack
Reason
Troponin I results in the Cardioimmune XL Control are measuring approximately 15-30% low in Levels 1 and 3 resulting in control measurements which are outside the published value assignment ranges. As a precaution, we are proactively recalling all levels associated with lot CXL1301. Only Troponin I control measurements are affected, all other control analyte measurements are recovering within the published value assignment ranges. We are currently investigating the root cause.
Affected products
A. MAS Cardioimmune XL, Level L
Lot or serial number
CXXL1301L
Model or catalog number
CAI-XLL
Companies
- Manufacturer
- Microgenics Corporation
B. MAS Cardioimmune XL, Levels 1, 2, 3
Lot or serial number
CXL13011, CXL13012, CXL13013
Model or catalog number
CAI-XL1, CAI-XL2, CAI-XL3
Companies
- Manufacturer
- Microgenics Corporation
C. MAS Cardioimmune XL, Multi-Pack
Lot or serial number
CXL13014
Model or catalog number
CAI-XL4
Companies
- Manufacturer
- Microgenics Corporation