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AIA -360 and AIA 600 II Systems (2016-07-13)
- Starting date:
- July 13, 2016
- Posting date:
- August 5, 2016
- 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-59706
Affected products
A. AIA-360 Analyzer System - Instrument
B. AIA-600 II System - Analyzer
C. AIA-600 II Automated Enzyme Immunoassay System - Instrument
Reason
There is a potential interference of Asfotase Alfa in Tosoh AIA assays. Patient samples may cause false elevated/decreased results.
Affected products
A. AIA-360 Analyzer System - Instrument
Lot or serial number
Not applicable
Model or catalog number
19945
Companies
- Manufacturer
-
Tosoh Corporation
Shiba-Koen First Bldg
3-8-2
105-8623
JAPAN
B. AIA-600 II System - Analyzer
Lot or serial number
Not applicable
Model or catalog number
19328
Companies
- Manufacturer
-
Tosoh Corporation
Shiba-Koen First Bldg
3-8-2
105-8623
JAPAN
C. AIA-600 II Automated Enzyme Immunoassay System - Instrument
Lot or serial number
Not applicable
Model or catalog number
19328
Companies
- Manufacturer
-
Tosoh Corporation
Shiba-Koen First Bldg
3-8-2
105-8623
JAPAN