| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00056-1 |
| Product Name/Description |
Pak Lx Assay
Product Code: GT-PLX
Lot Number: 3003658
with Conjugate Lot: 3003881
Lot Number: 3004022
with Conjugate Lot: 3003881
ARTG Number: 217307 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
Diagnostic Solutions has been informed by lmmucor GTI Diagnostics that the Conjugate Diluent included in Lots 3003658 and 3004022 has an expiration date defined on its labelling which is outside its supported stability. The expiration date for the Conjugate Diluent should be one year shorter than that provided on the labels. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Diagnostic Solutions is requesting users inspect their stocks and correct the expiry dates as per the new expiry dates given in the customer letter. This action has been closed-out on 07/09/2018. |
| Contact Information |
1300 788 003 - Diagnostic Solutions Customer Service |