| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01206-1 |
| Product Name/Description |
Polymer Refine Red Detection (used for testing and identification of neoplasm). An in vitro diagnostic medical device (IVD)
Product Code: DS9390
Lot Number: 41872
Expiry date: November 2016
ARTG Number: 211376 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
Leica Biosystems recently became aware that some detection kits may have been subject to a manufacturing error where some containers were under-filled and topped up with the incorrect reagent, leading to inadequate staining. If the product is used according to the Instructions for Use with the adequate controls, the end user would be able to identify the test has not stained correctly. |
| Recall Action |
Recall |
| Recall Action Instructions |
Leica Biosystems is advising users to discontinue use of the affected lot numbers and destroy any remaining stock.
Leica Biosystems is recommending consulting with the Laboratory Director and Physician to determine if a review of past results is warranted. This action has been closed-out on 29/08/2016. |
| Contact Information |
03 9211 7535 - Leica Biosystems |