AQT90Flex TnI (troponin) Test Kit. An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2014-RN-01304-1

Class II

2014-12-12

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01304-1

Radiometer has recently become aware of a potential risk of receiving a false high result when using the aqt90 flex tni test kit, 942-903, lot 09619. it has been reported that calibration adjustment cups may have been packed into the tni test kit cartridges of this lot. thus, in some test cartridges, one or more cups may be a calibration adjustment cup instead of a test cup.Patients receiving the erroneous result may be diagnosed as having an acute myocardial infarction and may immediately be subjected to standard treatment for this disease (such as surgical intervention percutaneous transluminal coronary angioplasty or treatment with fibrinolytic or other drugs). subsequent normal measurements of tni should result in recognition of the erroneous diagnosis and termination of the wrongful treatment.

Radiometer are advising their customers to: 1. Check inventory and remove all AQT90 FLEX TnI Test Kit Boxes of the affected lot 09619; 2. Discard all affected stock; and 3. Review any patient results, in conjunction with the Medical Director, where affected test kits are known to have been used.