| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00964-1 |
| Product Name/Description |
EnVision Flex/HRP visualisation reagent, part of EnVision Flex/Flex+ Kits
(For invitro diagnostics use. Intended for use in immunohistochemistry)
Multiple products affected
Product Codes: K8000, K8002, K8023, K8010, K8012, K8024 and GV800
Multiple Lot Numbers affected
ARTG Number: 199416 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
Dako has determined that there is a defect in one lot of a buffer used in the manufacturing of some corresponding lots of the EnVision FLEX/HRP visualisation reagent. Specifically, some instances of moderate-to-strong non-specific staining and overly-strong specific staining have been observed when this visualisation reagent was used with four antibodies against the biomarkers Epstein-Barr Virus (EBV), MUM-1, Wilms’ Tumor1(WT1) Protein and Smooth Muscle Actin (SMA). Negative control antibodies in the same run were negative, and did not show the non-specific staining. |
| Recall Action |
Recall |
| Recall Action Instructions |
Dako is advising users to destroy any remaining lots of affected units.
Dako is recommending that users re-evaluate test results from affected lots. This action has been closed-out on 25/08/2016. |
| Contact Information |
02 9922 0700 - Dako |