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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01265-1
Product Name/Description	AVOXimeter 1000E Cuvettes (used for oximetery assessment during heart catheterisation procedures). An in vitro diagnostic medical device (IVD). Product Code: C100B Lot Numbers: 607-108, 607-109, 607-110, 607-111, 607-112, 607-114, 607-115, 607-116, 607-117, 607-118, 607-119, 607-120, 607-122, 607-123, 607-124 ARTG Number 262423
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	29/09/2016
Responsible Entity	Zoll Medical Australia Pty Ltd
Reason/Issue	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.
Recall Action	Recall for Product Correction
Recall Action Instructions	Zoll Medical is advising users of the possibility of a downward shift in tHb values with the affected lots. This action has been closed out on the 01/11/2018.
Contact Information	02 8424 8720 - Zoll Medical Australia