| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00283-1 |
| Product Name/Description |
Immucor MATCH IT! DNA Software version 3.29.0 (released 30 Jan 2018) for use with Allele Database used with LIFECODES HLA-B SSO Typing Kits. In vitro diagnostic medical devices.
LIFECODES HLA-B SSO Typing Kit Affected Lots: 01117A (exp 30/11/2018) and 06036A (exp 31/05/2018)
Typing Kit Catalogue Numbers: TL628915 and TL628915s
ARTG Numbers: 257272 , 217871 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
4/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
Abacus has been advised by Immucor (the manufacturer), that as a result of a complaints investigation, it has been determined that the serological group for the B*27:08 allele was incorrectly assigned as Bw4. The correct serological group assignment for B*27:08 is Bw6. This assignment was part of the 3.29.0 allele database update.
Immucor confirm that there is no impact to the LIFECODES HLA-B SSO typing kits themselves.
Abacus Technical Support has confirmed that Australian customers do not currently utilise this component of the software, however, are rectifying the issue so it does not present a hazard in the future. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Abacus dx is advising that Immucor has created an executable file to correct the serological group assignment for B*27:08 when using the s.29.0 database update, which is available on the Immucor website. Customers are asked to upload this executable file before running LIFECODES HLA-B SSO typing kits.
Instructions for uploading this file to correct the serological group alignment are outlined on the Customer Letter.
This action has been closed out on 20/09/2018 |
| Contact Information |
1800 222 287 - Abacus |