Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2013-RN-01119-1
Product Name/Description i-STAT PT/INR Cartridge (prothrombin time test used for monitoring patients receiving oral anticoagulation therapy) (An in vitro diagnostic medical device (IVD))

List Number: 3P89-24

Lot Numbers: C103139 to and including C13270A

ARTG Number: 213851
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 1/11/2013
Responsible Entity Abbott Australasia Pty Ltd (Point-of-Care Division)
Reason/Issue Abbott Point of Care has determined that the i-STAT PT/INR cartridge lots have the potential to exhibit incorrectly elevated results. Internal studies have demonstrated that i-STAT PT/INR results are elevated by an average of approximately 10% as compared to the International Reference Preparation (rTF/09) in the therapeutic range of 1.8 to 3.0 INR.
Recall Action Recall
Recall Action Instructions Abbott Diagnostic is advising users to destroy unused stock. Any remaining stock will be replaced by Abbott. A review of previous results may be performed at the discretion of the laboratory manager.
Contact Information 1800 816 696 - Abbott Diagnostics Customer Support