| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01026-1 |
| Product Name/Description |
LIFECODES LifeScreen Deluxe (LMX). An in vitro diagnostic medical device (IVD).
Code Number: TL628215
Lot Number: 3002350
Expiration Date: 15 Nov 2015
ARTG Number: 217870 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
20/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
During stability testing at test point 9 months, with LMX lot 3002350, Immucor observed false positive results with a single sample. The sample is expected to test negative for both HLA Class I and Class II. The sample gave a qualitative result of CI (-), CII (+), indicating a false positive for HLA Class II. |
| Recall Action |
Recall |
| Recall Action Instructions |
Diagnostic Solutions is advising users to destroy any remaining stocks of the affected lots.
It is recommended that previously reported results are reviewed at the discretion of the laboratory director. This action has been closed-out on 19/08/2016. |
| Contact Information |
1300 788 003 - Customer Service |