The Therapeutic Goods Administration (TGA), Australia issued a medical device safety alert concerning i-STAT PT/INR Cartridge, manufactured by Abbott Point of Care Division. The affected list number is 3P89-24, and the affected lot numbers are 1 C103139 to and including C13270A.
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.
The manufacture advises users to destroy unused stock. Any remaining stock will be replaced by Abbott. Also, the manufacturer advises that a review of previous results may be performed at the discretion of the laboratory manager.
For details, please refer to TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01119-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 November 2013