Z-0220-2016Class II

EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision...

Name: Z-0220-2016 EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision...
Creator: Dako North America Inc.
Published: 2015-09-04
License: https://open.fda.gov/license/

Agilent Technologies, Inc. / initiated 2015-09-04 / Terminated

FDA source

Dako North America Inc. began a recall of EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini... on 2015-09-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0220-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-04
Posted: 2015-11-05
Terminated: 2016-04-25
Recalling firm: Agilent Technologies, Inc.
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.
Product code: LDT
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.
FDA root cause: Other
Action: Dako sent an customer notification letter on September 4, 2015, to all affected customers via mail. The letter identified the product the problem and the action needed to be taken by the customer. The customers/distributors are instructed in the Recall Notification Letters to 1) remove any unused kits bearing the affected lot numbers listed in their letter from diagnostic use 2) destroy any unused kits bearing the affect lot numbers listed in their letter, and 3) determine any possible impact of this change in performance on patient results from the affected lots. The letter states actions should be taken within 10 days and that customers/distributors should confirm they have received the information by returning the attached, fully completed Device Recall Form and return it to Dako QA Vigilance by email at [email protected]. The firm lists on their letter for customers to contact their Dako representative in there are any questions. For further questions, call (805) 566-6655.
Quantity in commerce: 300 units
Distribution: Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the states of : TX, SD, CA, FL, MA, MD, WV, NC, OH, DE, MI, NJ, CO, HI, AR, NY, LA, GA, NV, RI, IL, OK, CT, MO, VA, and DC., and to the countries of : Canada, Brazil and Costa Rica.
Product codes and lots: Item No.: K800021-2, K800221-2, K802321-2 (Link) K801021-2, K801221-2, K802421-2 (AS/AS+) GV80011-2, GV82311-2 (Dako Omnis) Catalog/Model No.: K8000 K8002 K8023 GV800 SM802 EnVision FLEX / HRP Lot 20019374 used in: Envision FLEX, High pH (link) Lot No.: 20019097, 20020777, 20021381 Envision FLEX+, Mouse, High pH (link) Lot No.: 20019103, 20019113, 20020772 EnVision FLEX Mini Kit, High pH (Link) Lot No.: 20021362 DM 842 EnVision FLEX / HRP (Dako Omnis) Lot 20019013 used in: EnVision FLEX, High pH (Dako Omnis) Lot No.: 20019102

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0220-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0220-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-05

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)