Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00230-1
Product Name/Description	i-STAT troponin I Assay Cartridges (cTnl). An in vitro diagnostic medical device (IVD) List Number: 06P23-25 Lot Number: P15293 ARTG Number: 213595
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	1/03/2016
Responsible Entity	Abbott Australasia Pty Ltd Point-of-Care Division
Reason/Issue	Abbott Point of Care (APOC) has determined that there is a possibility that a very small percentage of i-STAT cTnI cartridges distributed from the affected lot number may have a product identifier other than cTnI embossed on the thumbwell of individual cartridges. The outside box and cartridge pouch were labelled correctly for these specified lots. The cTnI cartridges from the affected lot can continue to be used for patient testing. The internal components, such as the reagent and analysis solution, are not impacted and the i-STAT system will appropriately recognise the cartridge as cTnI.
Recall Action	Recall for Product Correction
Recall Action Instructions	Abbott Point of Care is advising customers that a product replacement will be provided for any impacted stock.
Contact Information	1800 816 696 – Abbott Point of Care Technical Support