FDA-Device2016-08-10Class II
EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
Dako Denmark A/S
Hazard
The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.
Sold states
Worldwide Distribution -- US, Canada, and Colombia.
Affected count
147 kits
Manufactured in
Produktionsvej 42, Glostrup, Denmark
Products
EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2330-2016Don't want to check this manually?
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