The Australia Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning HemoCue Glucose 201 Microcuvettes single packed manufactured by HemoCue AB. The affected article number is 110718 and the affected lot number is 1310798.
The manufacturer has become aware that the HemoCue Glucose 201 Microcuvette 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.
According to the manufacturer, the microcuvettes of this specific lot number have now passed their expiry date and should have been used, or be discarded. The manufacturer recommends users that the need for repeat testing be determined by the laboratory or clinical director.
For details, please refer to the following link:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2014-RN-01197-1
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 12 November 2014