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INRatio Patient Self-Testing Monitoring System, INRatio PT Monitoring System (Professional Use) and INRatio Prothrombin Time/INR Strips (2014-12-09)
- Starting date:
- December 9, 2014
- Posting date:
- December 18, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-42959
Recalled Products
A) INRatio Patient Self-Testing Monitoring System
B) INRatio PT Monitoring System (Professional Use)
C) INRatio Prothrombin Time/INR Strips
Reason
In certain cases an INRatio PT/INR monitor system may provide an INR result that is significantly lower than a result obtained using a laboratory INR system. The plasma-based laboratory INR method is considered the most accurate and reliable INR method.
Affected products
A) INRatio Patient Self-Testing Monitoring System
Lot or serial number
All lots.
Model or catalog number
0200433
Companies
- Manufacturer
-
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego
92121
California
UNITED STATES
B) INRatio PT Monitoring System (Professional Use)
Lot or serial number
All lots.
Model or catalog number
0200431
Companies
- Manufacturer
-
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego
92121
California
UNITED STATES
C) INRatio Prothrombin Time/INR Strips
Lot or serial number
All lots.
Model or catalog number
0100071
0100139
Companies
- Manufacturer
-
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego
92121
California
UNITED STATES