Primus Corporation dba Trinity Biotech: The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. The unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.; The Control Level I material value was showing results exceeding th

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Sources: FDA iRES · Raw API Response

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