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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