Z-2330-2016Class II

EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry...

Name: Z-2330-2016 EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry...
Creator: Dako Denmark A/S
Published: 2016-07-06
License: https://open.fda.gov/license/

Agilent Technologies Denmark ApS / initiated 2016-07-06 / Terminated / root cause: manufacturing process

FDA source

Dako Denmark A/S began a recall of EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments on 2016-07-06. FDA classified it as Class II and gives the reason as "The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2330-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-06
Posted: 2016-08-03
Terminated: 2016-10-13
Recalling firm: Agilent Technologies Denmark ApS
Product: EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
Product code: LDT
Reason for recall: The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.
Root cause tag: manufacturing process
FDA 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 in commerce: 147 kits
Distribution: Worldwide Distribution -- US, Canada, and Colombia.
Product codes and lots: K8002 Lot no: 10112879 K8004 Lot no: 10111463

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2330-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2330-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-03

Product code LDT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)