| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00279-1 |
| Product Name/Description |
HemoCue Glucose 201 RT and Glucose 201 DM RT Systems (An in vitro diagnostic medical device (IVD) for the quantitative detection of blood glucose) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
28/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
During extended investigations on neonates it was confirmed that HemoCue Glucose 201 RT and HemoCue Glucose 201 DM RT perform according to specifications in all neonatal settings except neonatal intensive care. Critically ill neonates in intensive care settings often have immature metabolism in combination with complex treatment. This setting has not been fully evaluated for HemoCue Glucose 201 RT and Glucose 201 DM RT. Incorrect readings may lead to indirect harm to patients such as misdiagnosis or inappropriate treatment. Therefore the following text will be added to the Intended Use: "The system should not be used on critically ill neonates in neonatal intensive care settings". |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
HemoCue is enclosing adhesive labels with the updated intended use along with the customer letters so that end users can use this to cover the current intended use in the Operating Manual, Technical Specifications etc. |
| Contact Information |
02 4384 6855 - HemoCue Australia Pty Ltd |