Safety Information

Medsafe Online Recall Database

Type of Product:	Device
Medsafe Reference:	17852
Brand Name:	Alere INRatio & INRatio 2 PT/INR Monitoring System
Model:	All models
Affected:	All lots
Software version:
Recalling Organisation:	Abbott Laboratories (NZ) Ltd - Rapid Diagnostics Divison Ground Floor, Bldg. D 4 Pacific Rise Mount Wellington AUCKLAND 1060
Contact Information:	0800 466 951
Manufacturer:	Alere San Diego Inc
Issue:	The INRatio® and INRatio®2 PT/INR Monitor system should not be used on patients with any of the following conditions: * Anemia of any type with hematocrit less than 30% * Any conditions associated with elevated fibrinogen levels including: - Acute inflammatory conditions (examples may include acute viral or bacterial infections such as pneumonia or influenza) - Chronic inflammatory conditions (examples may include rheumatoid arthritis, Crohn's disease, ulcerative colitis, infectious liver diseases such as hepatitis, or inflammatory kidney diseases such as diabetic nephropathy and glomerulonephritis) - Severe infection (e.g., sepsis) - Chronically elevated fibrinogen for any reason - Hospitalized or advanced stage cancer or end stage renal disease patients requiring hemodialysis * Any bleeding or unusual bruising, clinically observed or reported by the patient
Recall action type:	Correction
Recall action:	Manufacturer to issue advice regarding use
Level of recall:	Public Recall
Date Commenced:	24/12/2014