| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00456-1 |
| Product Name/Description |
IH-1000 Immunohaemotology Analyser. An in vitro Diagnostic Medical Device (IVD)
Product REF: 001000
All software versions
ARTG number: 184446 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
16/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
An error relative to the liquid reagents management (test cells or anti-serum vials) might occur if the following conditions are present:
1. IH-1000 is in status “ready to start” and:
2. The user requests the unloading of a reagent rack while the system is creating the internal batch (the time slot during which the error could occur is about 2 seconds);
3. Another is loaded immediately afterwards in the same position.
If all three conditions are present, the IH-1000 may not use the full set of liquid reagents required to perform the tests of the ongoing batch.Due to a software failure, the system may only use the vial placed in the first position of the re-loaded rack for all the tests of the ongoing batch |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Bio-Rad is providing end users with work around instructions to mitigate the risk of incorrect results. A permanent correction will be made in the next software update. |
| Contact Information |
1800 224 354 - Bio-Rad Laboratories |