Device product
EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
Z-2330-2016
Product summary
- Firm
- Dako Denmark A/S
- Event
- Event 74608
- Status
- Terminated
- Classification
- Class II
- Quantity
- 147 kits
- Official record key
device-enforcement:Z-2330-2016
Official wording
Reason: The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.
Code information: K8002 Lot no: 10112879 K8004 Lot no: 10111463
Distribution pattern: Worldwide Distribution -- US, Canada, and Colombia.
Derived failure modes
-
Unknown
The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.