| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00753-1 |
| Product Name/Description |
HemoCue Urine Albumin Microcuvettes (an in vitro diagnostic medical device (IVD))
Lot Numbers: 1208848 to 1304847
ARTG Number: 137082 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
Hemocue has become aware of a production related problem that affects some single pack pouches of certain lots of Urine Albumin microcuvettes, where the foil within the pouch has been damaged. If a single pack pouch is damaged, the microcuvettes can be exposed to moisture which in some cases may lead to high false readings. |
| Recall Action |
Recall |
| Recall Action Instructions |
HemoCue is asking users to discontinue use of the affected lots. Affected product will be replaced by HemoCue. |
| Contact Information |
1800 623 910 - HemoCue Australia |