Dako Denmark A/S: Medical Device Recall in 2016 - (Recall #: Z-2330-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 6, 2016

Date Posted: August 10, 2016

Recall Number: Z-2330-2016

Event ID: 74608

Reason for Recall:

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

Status: Terminated

Product Quantity: 147 kits

Code Information:

K8002 Lot no: 10112879 K8004 Lot no: 10111463

Distribution Pattern:

Worldwide Distribution -- US, Canada, and Colombia.

Voluntary or Mandated:

Voluntary: Firm initiated