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All product recalls associated with Medtox Diagnostics Inc.
Total Recalls
970
Past Year
46
Class I (Serious)
16
Most Recent
Nov 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Reader was marketed without a 510(k).
Incorrect results: False reactive specimens on the ADVIA Centaur HAV IgM assay.
Incorrect results: CRP assays may be calculated using incorrect calibration parameters which could result in falsely high or falsely low patient results being reported.
False Results- The reagent of the LDL-Cholesterol assay shows a carryover effect on the Lipase assay. Results may be falsely elevated by up to 50 units per liter when used on COBAS INTEGRA 400 or COBAS INTEGRA 400+ analyzers.