FDA Device recall Z-2330-2016
EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004
- FDA Device
- Class II
- terminated
- Published 2016-08-10
On 2016-08-10 the FDA classified a Class II recall of EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004 by Dako Denmark A S, citing the pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2330-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-06 |
| Published | 2016-08-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Dako Denmark A S |
| Distribution | n/a |
Product
EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
Reason
The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.
Identifiers
| code_info | K8002 Lot no: 10112879 K8004 Lot no: 10111463 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2330-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.