Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

EnVision FLEX+ Recalled by Dako Denmark A/S Due to The pH of Target Retrieval Solution in the...

Date: July 6, 2016
Company: Dako Denmark A/S
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Dako Denmark A/S directly.

Affected Products

EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.

Quantity: 147 kits

Why Was This Recalled?

The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.

Where Was This Sold?

Worldwide Distribution -- US, Canada, and Colombia.

About Dako Denmark A/S

Dako Denmark A/S has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report