AVOXimeter 1000E Cuvettes (used for oximetery assessment during heart catheterisation procedures). An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2016-RN-01265-1

Class II

2016-09-29

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01265-1

It has been determined that a limited number of avoxmeter 1000e cuvettes have exceeded internal control limits for gap measurement. the gap measurement is incorporated into the pathlength value, which in turn is entered into the settings of avoximeter instruments when a new lot of cuvettes are used to run a test. the pathlength values add an additional degree of accuracy in the total haemoglobin (thb) reported value and those calculations where thb is used as a variable. the pathlength values do not affect %02hb, %cohb or %methb results.The affected avoximeter cuvettes may have a slight upward shift in pathlength that can result in a clinically insignificant corresponding downward shift in thb. in a worst case, this shift may cause the reporting of a thb result approximately 5% lower than the actual thb value (e.G. an actual value of 10 g/dl is reported as 9.5 g/dl). the shift presents a low risk to health in the intended clinical uses associated with the avoximeter system.

Zoll Medical is advising users of the possibility of a downward shift in tHb values with the affected lots.