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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-01197-1
Product Name/Description HemoCue Glucose 201 Microcuvettes single packed

Article Number: 110718

Affected Lot Number: 1310798
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 10/11/2014
Responsible Entity HemoCue Australia Pty Ltd
Reason/Issue HemoCue has become aware that the HemoCue Glucose 201 Microcuvette (lot number110718) may, at the end of their shelf-life, yield measurements higher than expected. The higher glucose values may have led to unnecessary insulin treatment or lack of glucose treatment.
Recall Action Recall for Product Correction
Recall Action Instructions The microcuvettes of this specific lot number have now passed their expiry date and should have been used, or be discarded. It is recommended that the need for repeat testing be determined by the laboratory or clinical director. This action has been clsoed-out on 22/08/2016.
Contact Information 1800 623 910 - HemoCue Australia