| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00591-1 |
| Product Name/Description |
LIFECODES HLA-C eRES SSO Typing Kit. An in vitro diagnostic medical device (IVD)
Product Code: TL628921
Lot Number: 10235B
Probes affected: 380, 382, 384, 385
ARTG Number: 217872 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has been determined that the threshold set for HLA-C eRES Probes 380, 382, 384 and 385 in Lot Number 10235B are set high and may result in false negative probe results. The probes resolve the following CWD alleles:
• Probe 380 resolves C*03:06
• Probe 382 resolves C*12:13
• Probe 384 resolves C*01:08
• Probe 385 resolves C*08:06 |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Diagnostic Solutions is advising users a correction will be made by replacing the old HLA-C eRES MATCHIT! EXP file with a revised MATCHIT! EXP file, which is specific to this single lot. This action has been closed-out on 02/02/2017. |
| Contact Information |
1300 788 003 - Diagnostic Solutions Customer Service |