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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