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All product recalls associated with Trinity Biotech USA.
Total Recalls
3
Past Year
1
Class I (Serious)
0
Most Recent
Jul 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.
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months.
Prolongation of Prothrombin times in patient samples, resulting in a falsely elevated INR value.