| 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 |
|
| 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 |