EnVision FLEX+ recall
EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
Why was EnVision FLEX+ recalled?
The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
K8002 Lot no: 10112879 K8004 Lot no: 10111463
- Product
- EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
- Recalling firm
- Dako Denmark A/S
- Quantity
- 147 kits
- Distribution
- Worldwide Distribution -- US, Canada, and Colombia.
- Recall date
- August 10, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)