FDA Medical Device Recalls (openFDA)
Dako Denmark A/S: EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
- Recall number
- Z-2330-2016
- Recalling firm
- Dako Denmark A/S
- Product
- EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
- Status
- Terminated
- Initiated
- 2016-07-06
- Posted
- not on file
- Terminated
- 2016-10-13
- Reason
- The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.
- Root cause
- Process control
- Action
- A recall notification letter dated 7/6/16 was sent to customers to inform them that Dako is recalling EnVision FLEX+ kit because the pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1. The letter informs the customers that with a pH of 4-5 instead of pH 9 there could be weak staining, false negative or false positive non-specific staining depending on the antibody used. There is the possibility that this staining could lead to a false result. Customers are to discard the affected product, determine the impact as instructed, and confirmed that they have received replacement kits. Customers are instructed to complete the Device Recall Form and contact local sales representative for any questions regarding the recall notification.
- Quantity
- 147 kits
- Distribution
- Worldwide Distribution -- US, Canada, and Colombia.
- Lot, serial or model codes
- K8002 Lot no: 10112879 K8004 Lot no: 10111463
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LDT
- Firm FEI
- 3002806778
- Firm city
- Glostrup
- Firm state
- not on file
- Firm country
- Denmark
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28