| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00782-1 |
| Product Name/Description |
HemoCue Glucose 201 RT Microcuvettes, single pack. An in vitro diagnostic medical device (IVD)
Lot Number: 1209937, 1210951, 1303992 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
5/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
Hemocue has become aware of a production related problem that affects some single pack pouches of certain lots of Glusoce RT 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 a measurement deviating +/- 2mmol/L. |
| Recall Action |
Recall |
| Recall Action Instructions |
HemoCue is asking users to discontinue use of the affected lots as the affected microcuvettes may display a measurement deviation of +/- 2mml/L. Affected product will be replaced by HemoCue. |
| Contact Information |
1800 623 910 - HemoCue Australia |