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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00749-3
Product Name/Description HemoCue Glucose 201 RT and 201 DM RT Systems. A point of care in vitro diagnostic medical device (IVD).

Affected Product Numbers: 124713 and 124013
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 26/07/2012
Responsible Entity HemoCue Australia Pty Ltd
Reason/Issue HemoCue has become aware of indications of in-correct high readings of HemoCue Glucose 201 RT and HemoCue Glucose 201 DM RT for the application of monitoring of blood glucose levels on pre-term neonates. On full-term neonates there are no similar indications but as a precaution HemoCue has decided to replace all systems on delivery and neonatal wards with HemoCue Glucose 201+ or HemoCue Glucose 201 DM while investigations continue.
Recall Action Recall
Recall Action Instructions HemoCue is recalling affected devices and is replacing them with unaffected models
Contact Information 02 4384 6855 - Danielle Brown