Medical device recalls Moderate risk

Dako Denmark A/S recalls EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with…

Recall date
July 6, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2330-2016
FDA classification
Class II
Brand / firm
Dako Denmark A/S
Sold / distributed
Worldwide Distribution -- US, Canada, and Colombia.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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