| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00593-1 |
| Product Name/Description |
IH-1000. An in vitro diagnostic medical device (IVD)
All software versions are affected
Product reference: 001000
ARTG Number: 184446 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
13/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
In some specific conditions, inconsistent grading between the results in the well/card and the results returned by the IH-1000 may be observed. In these very specific conditions, positive reactions might be read as negative by the system due to the analysis algorithm of the images.
Therefore this issue might lead to a wrong result released to the host if the 3 following conditions are met:
1 A result is returned as negative while the reaction is positive, Double Population, or requires a human interpretation and,
2. This negative result is consistent with the global interpretation of the test and,
3. The system is configured without the second reading function activated for all tests results. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Bio-Rad are providing work around instructions as an interim measure. A software update will be implemented to permanently correct the issue. |
| Contact Information |
1800 224 354 - Bio-Rad Product Specialist |