EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
Recall
- Recall Number
- Z-2330-2016
- Event Number
- 74608
- Firm
- Dako Denmark A/S Produktionsvej 42 Glostrup Denmark
- FEI Number
- 3002806778
- Product Code
- LDT
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- July 6, 2016
- Terminated
- October 13, 2016
Description
EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.
A recall notification letter dated 7/6/16 was sent to customers to inform them that Dako is recalling EnVision FLEX+ kit because the pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1. The letter informs the customers that with a pH of 4-5 instead of pH 9 there could be weak staining, false negative or false positive non-specific staining depending on the antibody used. There is the possibility that this staining could lead to a false result. Customers are to discard the affected product, determine the impact as instructed, and confirmed that they have received replacement kits. Customers are instructed to complete the Device Recall Form and contact local sales representative for any questions regarding the recall notification.
Worldwide Distribution -- US, Canada, and Colombia.
147 kits