| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00099-1 |
| Product Name/Description |
D-10 Rack Loader. An in vitro diagnostic medical device (IVD).
Catalogue Number: 220-0600
ARTG Number: 212703 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential for a sample and result to be mismatched when running in the D-10 Rack Loader configuration. This means that a patient result may be assigned to an incorrect sample ID. While only two instances have been reported, Bio-Rad wants users to be aware of the possibility. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Bio-Rad is investigating the reported issue and preparing a permanent solution. In the interim, users are advised to not skip positions within the rack. While reviewing results, check the Daily Summary for the following:
A. Confirm that the number of results equals the total number of samples run.
B. Confirm that injection numbers (I#) within an individual rack (R#) are consecutive.
C. Confirm that any sample that was assigned an auto-generated Sample ID is actually missing a barcode label on the sample tube.
Bio-Rad Laboratories will release a follow-up communication providing a permanent solution upon completion of a thorough investigation. |
| Contact Information |
1800 224 354 - Bio-Rad Laboratories |