| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00241-1 |
| Product Name/Description |
Various ID-Diacell Products. An in vitro diagnostic medical device (IVD).
ID-DiaCell Pool
ID-DiaCell ABO/I-II
ID-DiaCell ABO/I-II-III
ID-DiaCell I-II
ID-DiaPanel
ID-DiaCell I-II-III
ID-DiaCell I-II-III Asia
ID-DiaScreen Prophylax
ID-DiaPanel Plus 6
ID-DiaCell ABO
ID-DiaCell lP-llP-lllP
ID-DiaPanel-P
Multiple Catalogue Numbers
All unexpired lots
ARTG Number: 213161 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
Bio-Rad has identified an issue in relation to unexpected reactions primarily on eluates and QC samples but also with some patient samples when using ID-Diacell products. There is the potential for false positive results. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Bio Rad Laboratories is advising users to re-test with a new kit if they are doubtful of the results and if doubts remain after re-testing, to use an alternative testing method. Users are further advised to disseminate this information to relevant personnel within their facilities.
This action has been closed-out on 21/03/2018. |
| Contact Information |
1800 224 354 - Bio-Rad Laboratories |