Recall Z-2330-2016— Dako Denmark A/S
Class II · Terminated
Class II FDA medical device recall by Dako Denmark A/S, initiated 2016-07-06, terminated 2016-10-13. FDA's recall record names no specific 510(k) clearance for this event. Product: EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.. Reason: The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1..
- Recalling firm
- Dako Denmark A/S
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-07-06
- Terminated
- 2016-10-13
- Firm location
- Glostrup, Denmark
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.