EnVision FLEX/HRP visualization reagent found in the following kits:… — Class II medical device recall Z-0220-2016
Terminated recall by Dako North America Inc., reported 2015-11-11, distributed nationwide. There is a defect in one lot of a buffer, non-specific background staining that has, in some instances, interf
| Recall number | Z-0220-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dako North America Inc., Carpinteria, CA, United States |
| Recall initiated | 2015-09-04 |
| Classified | 2015-11-05 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2016-04-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, CR |
| Quantity | 300 units |
| Lot numbers | 20019013, 20019097, 20019102, 20019103, 20019113, 20019374, 20020772, 20020777, 20021362DM, 20021381, 842 |
| Model numbers | GV800, K8000, K800021-2, K8002, K800221-2, K8023, K802321-2, SM802 |
Product
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
Reason for recall
There is a defect in one lot of a buffer, non-specific background staining that has, in some instances, interfered with interpretation of the staining results.
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-0220-2016. 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.