| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00694-1 |
| Product Name/Description |
HemoCue Glucose 201 Microcuvettes, single packed (an in vitro diagnostic medical device (IVD))
Model Number: 110718
Affected lot numbers: 1208502, 1208799, 1209536, 1210565, 1301706, 1302764, 1303525, 1303784 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
Hemocue has become aware of a production related problem that affects some single pack pouches for the affected microcuvettes, where the foil within the pouch has been damaged. If a single pack pouch is damaged, the microcuvette can be exposed to moisture which in some may lead to low false readings. |
| Recall Action |
Recall |
| Recall Action Instructions |
HemoCue is requesting users to destroy or return affected stock for replacement with unaffected stock. |
| Contact Information |
1800 623 910 - HemoCue Australia |