| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00997-1 |
| Product Name/Description |
Lifecodes HLA-DRB1 SSO Typing Kit and HLA-DQA1/B1 Typing Kit. An in vitro diagnostic medical device (IVD)
HLA-DRB1 SSO Typing Kit
Supplier Code: 628923
Lot Numbers: TL628923 and TL628923s
Lot Numbers: 04226A and 11125A
HLA-DQA1/B1 SSO Typing Kit
Supplier Code: 628930
Lot Numbers: TL628930, TL628930s and TL628930p
Lot Numbers: 3004970, 06306A and 10205A
ARTG Numbers: 217874 and 217873 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
Diagnostic Solutions has been informed by the manufacturer lmmucor GTI Diagnostics, that there is an error in the probe lot specific files and probe hit tables in the MATCH IT! DNA 3.27.0 Allele Database update sent to customers in May 2017. The error impacts specific kits and lots numbers only.
The error results in an incorrect typing for some non-common well defined alleles. However, the affected alleles are still correctly typed at low resolution. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
1. Complete the supplied response form. If any of the affected stock could have been transferred from your Laboratory to another, please immediately forward a copy of this letter to relevant staff.
2. Retain this letter in a prominent position until the database is updated.
3. A representative from Diagnostic Solutions will be in contact with users as soon as the database update is available.
4. Consider re-analysing the data once the database update is made.
This action has been closed out on the 17/10/2018. |
| Contact Information |
1300 788 033 - Diagnostic Solutions Customer Service |