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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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