PlainRecalls

Dako North America Inc.

Compiled from official public sources by the publisher.

8 recalls on record · Latest: Jul 18, 2018

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Agency notice ledger

Federal filing book Dako North America Inc. LIGHT-BOOK · SINGLE-AGENCY

#1,726 of 14,151 · 8 notices · 0.008% archive

  • BOOK 8 notices
  • RANK #1,726 of 14,151
  • SHARE 0.008% archive
  • AGENCY FDA Devices (8)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jul 18, 2018
  • PHOTO Ab Sciex

Nearest notice-volume peer: Ab Sciex (0 notice gap)

Dako North America Inc. accounts for about 0.008% of the 104,423-notice archive on 8 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Dako North America Inc. compares to 14,151 recalling firms

Dako North America Inc. ranks 1,726th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Dako North America Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

8 1726th of 14151 higher than 12,296 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Dako North America Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Dako North America Inc. holds about 0.008% of archive notices alongside 8 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Jul 18, 2018

PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.
FDA Devices Moderate Jul 6, 2016

Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same
FDA Devices Moderate Nov 11, 2015

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.
FDA Devices Moderate May 6, 2015

Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro diagnostic use. The TRD is intended to distribute patient case, appropriate parts information, track changes, and transform test requests from LIS or manual entries to connected Dako systems.
FDA Devices Moderate Mar 18, 2015

Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.
FDA Devices Moderate Oct 1, 2014

Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic use. The Dako Autostainer Link 48 is an automated slide processing system compatible with reagents for the staining of paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates. The system is designed to automate manual staining methods routinely used in immunohistochemistry and cytochemistry, enabling the transfer of established protocol
FDA Devices Moderate Mar 5, 2014

Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic si
FDA Devices Moderate Nov 21, 2012

PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures.

Dako North America Inc. holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (8 here).

Ab Sciex 8 Acumedia Manufacturers, Inc. 8 Adept Medical Ltd 8 Aju Pharm Co., Ltd. 8 Ambriola Co., Inc., The 8

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Ab Sciex 8 Acumedia Manufacturers, Inc. 8 Adept Medical Ltd 8 Aju Pharm Co., Ltd. 8

Frequently Asked Questions

How many federal recall notices name Dako North America Inc.? ▼
PlainRecalls indexes 8 distinct federal recall events naming Dako North America Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Dako North America Inc. sit among other recalling firms? ▼
Dako North America Inc. ranks #1,726 of 14,151 by distinct recall-event count among 14,151 firms in this archive (87th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Dako North America Inc.'s notices? ▼
FDA Devices accounts for 8 of this firm's 8 indexed notices.
What product category dominates Dako North America Inc.'s filing book? ▼
Filings for Dako North America Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Dako North America Inc.: 8 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Dako North America Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026