CLASS II Device recall · Reported 11 Nov 2015 · FDA Enforcement Report

EnVision Flex/Hrp visualization reagent found recalled

Dako North America is recalling EnVision Flex/Hrp visualization reagent found in the following kits: EnVision Flex, High, distributed nationwide in the US. The recall was initiated on 4 Sep 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem 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

Quantity recalled300 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0220-2016
FDA event ID: 72097
Recalling firm: Dako North America, Carpinteria, CA
Classification: Class II
Status: Terminated
Recall initiated: 4 Sep 2015
FDA classified: 5 Nov 2015
Reported: 11 Nov 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Test Kits & Diagnostics

Timeline

4 Sep 2015	Recall initiated by company
5 Nov 2015	Classified by FDA	+62 days
11 Nov 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Arkansas California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Illinois Louisiana Massachusetts Maryland Michigan Missouri North Carolina New Jersey Nevada New York Ohio

Questions about this recall

Is EnVision Flex/Hrp visualization reagent found in the following kits: EnVision Flex, High recalled?

Yes. Dako North America recalled EnVision Flex/Hrp visualization reagent found in the following kits: EnVision Flex, High on 4 Sep 2015. The recall is Class II and its status is Terminated. Recall number Z-0220-2016.

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Dako North America

All 8

Reported	Class	Recall	Company	Reason	Where
18 Jul 2018Device	CLASS II	PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to recalled	Dako North America	Other	29 states
6 Jul 2016Device	CLASS II	Dako HER2 CISH pharmDx Kit, product recalled by Dako North America	Dako North America	Other	Nationwide
6 May 2015Device	CLASS II	Test Request Distributor (TRD 3 and TRD 4) recalled	Dako North America	Device Malfunction	Nationwide
18 Mar 2015Device	CLASS II	Autostainer Plus Link Instrument (AS100) recalled by Dako North America	Dako North America	Packaging Defects	Nationwide
1 Oct 2014Device	CLASS II	Dako Autostainer Link recalled by Dako North America	Dako North America	Device Malfunction	Nationwide

Other Test Kits & Diagnostics recalls

All 2,656

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	STA Staclot Protein S recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	Syva EMIT 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Lead & Heavy Metals	Nationwide
26 Aug 2026Device	CLASS II	Beckman Coulter, Emit 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Lead & Heavy Metals	Nationwide