Ortho Clinical Diagnostics has observed an increase in complaints, and confirmed observed imprecision, for low-level quality control (QC) and patient samples at the low end of the measuring (reportable) range when using Vitros FSH, LH and PROL reagent. Complaints have also been received regarding calibration failures, driven by imprecision observed with calibrator level 1. The investigation indicates the imprecision is caused by additional signal generated during processing, resulting in falsely elevated results. This additional signal is caused by an interaction between reagent lots and some Vitros systems. While all reagent lots have the potential for imprecision, the majority of customers are not affected as we have confirmed that not all vitros systems exhibit the issue. Recall start date: Mar 25, 2022
RecallTracker