| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00161-1 |
| Product Name/Description |
HemoCue WBC Diff analysers and WBC Diff Microcuvettes. An in vitro diagnostic medical device (IVD)
All Serial Numbers
ARTG Numbers: 222568, 222701
(Radiometer Pacific - Haematology full blood count IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
No specific limitations are given in the indications for use for the system. However, HemoCue has become aware that there is a need to clarify that use of the HemoCue WBC Diff system on patients on chemotherapy, other immunosuppressive therapies or on drugs with immunosuppressive effects, has not been fully evaluated by HemoCue AB.
Risk
If incorrect results are obtained for these patient populations it could potentially lead to a delay in a dose modification and increased infection risk.
Hemocue will be updating the Instruction for use for the WBC DIFF system to include the above clarification. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Radiometer will be providing updated instructions for use to provide clarification regarding the use of the HemoCue WBC Diff system on patients on chemotherapy, other immunosuppressive therapies or on drugs with immunosuppressive effects.
This action has been closed out on 19/11/2018 |
| Contact Information |
1800 247 254 - Customer Service Support |