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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00782-1
Product Name/Description HemoCue Glucose 201 RT Microcuvettes, single pack. An in vitro diagnostic medical device (IVD)

Lot Number: 1209937, 1210951, 1303992
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 5/08/2013
Responsible Entity HemoCue Australia Pty Ltd
Reason/Issue Hemocue has become aware of a production related problem that affects some single pack pouches of certain lots of Glusoce RT microcuvettes, where the foil within the pouch has been damaged. If a single pack pouch is damaged, the microcuvettes can be exposed to moisture which in some cases may lead to a measurement deviating +/- 2mmol/L.
Recall Action Recall
Recall Action Instructions HemoCue is asking users to discontinue use of the affected lots as the affected microcuvettes may display a measurement deviation of +/- 2mml/L. Affected product will be replaced by HemoCue.
Contact Information 1800 623 910 - HemoCue Australia