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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01364-1
Product Name/Description	Citrate Activated Partial Thromboplastin Time (APTT) Cuvettes. An in vitro diagnostic medical device (IVD) Lot Numbers: E3JCC013-P1, E3JCC014-P2 Expiry Date: 2014 - 05
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	24/12/2013
Responsible Entity	Zoll Medical Australia Pty Ltd
Reason/Issue	The manufacturer, ITC has determined that Citrate APTT cuvettes from the lots listed above may recover higher than expected results in normal individuals. ITC’s investigation into the affected lots identified that when performing tests on non-heparinized e.g., normal blood samples, results may average higher than historic values. Test results performed on patients receiving heparin therapy are not affected. ITC has evaluated the risk to health using the affected device and has determined under a variety of clinical conditions, an erroneous increase in the citrated APTT baseline may contribute to serious injury.
Recall Action	Recall
Recall Action Instructions	Zoll Medical Australia is requesting their customers to inspect their stock and quarantine all affected lots of the product. Zoll Medical Australia will arrange for the recovery and replacement of stock. Customers are advised that the requirement for retesting reported patient results should be discussed with the Laboratory Director.
Contact Information	1800 605 555 - Zoll Medical Australia