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EN VISION FLEX / EN VISION FLEX+ DETECTION KITS (2015-09-02)
- Starting date:
- September 2, 2015
- Posting date:
- September 29, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-55130
Recalled Products
- EnVision FLEX+, Mouse, High pH (link)
- EnVision FLEX, High pH (Dako Omnis)
Reason
An increasing number of complaints regarding Dako EnVision FLEX detection systems have been noted. Using four antibodies against the biomarkers Epstein - Barr virus (EBV), MUM-1, smooth muscle actin (SMA), and Wilms' tumor 1 (WT1) protein have reported non-specific background staining that has in some instances, interfered with interpretation of staining results.
Affected products
A. EnVision FLEX+, Mouse, High pH (link)
Lot or serial number
20019102
Model or catalog number
K8002
Companies
- Manufacturer
-
DAKO Denmark A/S
Produktionsvej 42
Glostrup, Copenhagen
2600
DENMARK
B. EnVision FLEX, High pH (Dako Omnis)
Lot or serial number
20019103
Model or catalog number
GV800
Companies
- Manufacturer
-
DAKO Denmark A/S
Produktionsvej 42
Glostrup, Copenhagen
2600
DENMARK