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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00549-1
Product Name/Description i-STAT PT/INR Cartridges
(prothrombin time test)

List Number: 03P89-24

Lot Number: All lots from S15007 to S15026 inclusive and All lots from T15037A to T15076A inclusive

ARTG Number: 213851
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 26/06/2015
Responsible Entity Abbott Australasia Pty Ltd Point-of-Care Division
Reason/Issue Abbott Point of Care Inc. (APOC) has determined that certain lots of i-STAT PT/INR cartridges may generate a higher than typical number of PT/INR star outs, due to the internal quality system suppressing results if the analyser or cartridge does not meet certain internal specifications. There is a potential to delay the generation of patient results for PT/INR due to the star outs. When results are generated they are within the expected performance of the assay.
Recall Action Recall for Product Correction
Recall Action Instructions Cartridges can continue to be used for patient testing. If you repeatedly observe the condition where cartridges from the lots listed above display star outs, please contact Abbott Customer Support for your country and they will organise replacement of impacted stock. This action has been closed-out on 02/05/2017.
Contact Information 1800 816 696 - Abbott Customer Support