| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00898-1 |
| Product Name/Description |
ALBAclone Anti-Leb, (LEB2) 1 x 5mL
(Immunoglobulins capable of binding to specific red blood cell antigens and intended to be used in immunohaematological testing to provide information about red blood cell antigen phenotypes.)
Product Code: Z217
Lot Number : V158461
ARTG Number: 225063 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
Potential patient risk:-
Performance issues have been identified during internal use of the reagent. It has been determined that there is a potential for weak or false negative results with some Leb positive blood cells. |
| Recall Action |
Recall |
| Recall Action Instructions |
Affected units are being recalled from the market. This action has been closed-out on 20/06/2016. |
| Contact Information |
03 9708 6299 - Haemokinesis |