| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01115-1 |
| Product Name/Description |
HemoCue HbA1c 501 Test Cartridge. An in vitro diagnostic medical device (IVD)
Lot Number: F14K12K21DL
ARTG Number: 206986 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
16/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has advised that some of the HbA1c501 test cartridges may give elevated results. As the HbA1c501 is used to provide the average glucose concentration over a period of time for patient management and not immediate treatment, an elevated result would not impact patient management. |
| Recall Action |
Recall |
| Recall Action Instructions |
Radiometer is advising users to discard any remaining stock. This action has been closed-out on 18/08/2016. |
| Contact Information |
1800 247 254 - HemoCue Product Manager |