| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00169-1 |
| Product Name/Description |
ABC1 HLA Typing Tray included in ABC1 / ABC2 Kits. An in vitro diagnostic medical device (IVD).
Product Code: GT-ABC1/2AU
Lot Number: 3004753
Expiration Date: 15 Nov 2017
ARTG Number: 236406 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
ABC1 HLA Typing Trays included in a single lot of ACB1/ACB2 kits contain a manufacturing defect that can result in false positive or false negative results. |
| Recall Action |
Recall |
| Recall Action Instructions |
Diagnostic Solutions is advising customers to immediately discontinue use of and destroy ABC1 HLA Typing Trays from the affected lot. Replacement kits will be provided. It is recommended that previously reported results are reviewed at the discretion of the clinical or laboratory director. This action has been closed out on 16 June 2017. |
| Contact Information |
1300 788 003 - Diagnostic Solutions Customer Service |