| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00280-1 |
| Product Name/Description |
D-10 Haemoglobin Testing System. An in vitro diagnostic medical device (IVD)
Catalogue Number: 220-0220 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
On a rare occasion, the D-10 software might generate an extra result by duplicating the result from the previous sample and the Sample ID/Injection # from the next sample. The duplicate is readily detectable when sorting the Daily Summary by the injection # and reviewing for duplication of the same sample ID number. Such duplication could potentially lead to discrepant sample results, which should not be reported. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Bio-Rad are providing users with work around instructions to follow as an interim measure. Bio-Rad will release a permanent solution when available. This action has been clsoed-out on 18/02/2016. |
| Contact Information |
1800 224 354 - Bio-Rad Tech Support |