Z-2330-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 10, 2016
- Initiation Date
- July 6, 2016
- Termination Date
- October 13, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 147 kits
Product Description
EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
Reason for Recall
The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.
Distribution Pattern
Worldwide Distribution -- US, Canada, and Colombia.
Code Information
K8002 Lot no: 10112879 K8004 Lot no: 10111463