| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00825-1 |
| Product Name/Description |
HemoCue Hb 201 Microcuvettes (an in vitro diagnostic medical device (IVD))
Lot Numbers: 12086555, 1208660, 1209669, 1209674, 1210688, 1211697, 1301708, 1301717, 1322723, 1303734
ARTG Number: 137082 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
8/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
Hemocue has become aware of a production related problem that affects some single pack pouches of certain lots of HemoCue Hb 201 microcuvettes, where the foil within the pouch has been damaged. If a single pack pouch is damaged, the microcuvettes can be exposed to moisture the cuvettes will not fill properly and no measurement will be given. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
HemoCue is asking users to discard any affected microcuvettes as per the Instructions for Use. Replacement of affected units can be arranged by consulting HemoCue. |
| Contact Information |
1800 623 910 - HemoCue Australia |