| 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 |
|
| 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 |