Diamedix Corporation

Complete recall history across all FDA and CPSC categories — 7 total recalls

Diamedix Corporation 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 (7)

FDA medical device enforcement actions by Diamedix Corporation

Date Product Reason Class
Jan 5, 2018 Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic ... Contains a gel-like contaminant that may affect product performance. Class III
Jan 5, 2018 Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use... Contains a gel-like contaminant that may affect product performance. Class III
Mar 26, 2015 Diamedix Is-CMV IgG Test Kit Product contained an incorrect substrate. Class II
Oct 20, 2014 Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA p... A gel-like substance was found in kit component, sample diluent , that could ... Class II
Oct 20, 2014 Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EI... A gel-like substance was found in kit component, sample diluent , that could ... Class II
Oct 20, 2014 Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA... A gel-like substance was found in kit component, sample diluent , that could ... Class II
Aug 6, 2012 The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diame... Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive C... 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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