Dako Denmark A/S

Complete recall history across all FDA and CPSC categories — 3 total recalls

Dako Denmark A/S 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 (3)

FDA medical device enforcement actions by Dako Denmark A/S

Date Product Reason Class
Nov 5, 2019 Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer... The Autostainer instrument may not have a syringe tray installed which could ... Class II
Jul 6, 2016 EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended ... The pH of Target Retrieval Solution in the kit measures 4-5 instead of the co... Class II
Nov 26, 2012 CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the... The expected life time of the CoverStainer slide racks (CS 10330) does not me... 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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