Reported Aug 10, 2016 · Terminated

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

Dako Denmark A/S

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Dako Denmark A/S · Produktionsvej 42 · Glostrup · N/A

Is this the product you have?

  • EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
Lot codes and dates
  • K8002 Lot no10112879
  • K8004 Lot no10111463
Amount recalled
147 kits

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 13, 2016 · Data as of Sep 19, 4:44 PM UTC

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