Recall Z-0220-2016— Dako North America Inc.
Class II · Terminated
Class II FDA medical device recall by Dako North America Inc., initiated 2015-09-04, terminated 2016-04-25. FDA's recall record names no specific 510(k) clearance for this event. Product: EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.. Reason: There is a defect in one lot of a buffer, non-specific background staining that has, in some instances, interfered with interpretation of the staining results..
- Recalling firm
- Dako North America Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-04
- Terminated
- 2016-04-25
- Firm location
- Carpinteria, CA, United States
Product description
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
Reason for recall
There is a defect in one lot of a buffer, non-specific background staining that has, in some instances, interfered with interpretation of the staining results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.