Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19174 |
| Brand Name: | Dako EnVision FLEX/HPR reagent |
| Model: | K8000 & K8012 |
| Affected: | 20019097 & 20020768 |
| Software version: | |
| Recalling Organisation: | Global Science a Bio-Strategy Company (Bio-Strategy Limited) 241 Bush Road Albany Auckland 0632 |
| Contact Information: | 0800 734 100 |
| Manufacturer: | DakoCytomation |
| 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 visualization reagent. Specifically, some instances of moderate-to-strong non-specific staining and overly-strong specific staining have been observed when this visualization 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. 15/01/2016: Subsequent to the earlier letter the remaining Dako FLEX Ready-to use antibodies were tested using the affected EnVision FLEX/HRP visualization reagent . Two additional antibodies wereidentified as having a remote potential to affect results. Update overview letter sent. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/9/2015 |
