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Dako North America Inc.

Complete recall history across all FDA and CPSC categories — 8 total recalls

Dako North America Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (8)

FDA medical device enforcement actions by Dako North America Inc.

Date Product Reason Class
Feb 2, 2018 PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 leve... To correct the kit's instructions for use as the storage time for gastric and... Class II
Jun 10, 2016 Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vi... An incorrect HER2 probe concentration was used when producing the probe compo... Class II
Sep 4, 2015 EnVision FLEX/HRP visualization reagent found in the following kits: EnVisio... There is a defect in one lot of a buffer, non-specific background staining th... Class II
Apr 1, 2015 Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the... If a user requests slides from the LIS or TPID, then updates a request by cha... Class II
Feb 12, 2015 Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autost... A false negative result affecting the diagnosis may occur. A defect in the sy... Class II
Aug 29, 2014 Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS4... Dako is recalling the Dako Link 4.0.3 software on the Dako Autostainer Link 4... Class II
Jan 21, 2014 Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 2000091... Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signa... Class II
May 1, 2008 PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an auto... Dako is recalling the PT Link Waterbath because of a possible electrical haza... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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