EnVision FLEX+ — Class II medical device recall Z-2330-2016
Terminated recall by Dako Denmark A/S, reported 2016-08-10. The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.
| Recall number | Z-2330-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dako Denmark A/S, Glostrup, Denmark |
| Recall initiated | 2016-07-06 |
| Classified | 2016-08-03 |
| Reported by FDA | 2016-08-10 |
| Terminated | 2016-10-13 |
| Countries outside the US | CA, CO |
| Quantity | 147 kits |
| Lot numbers | 10111463, 10112879, K8004 |
Product
EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
Reason for recall
The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2330-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.