QuidelOrtho™ received complaints on the affected coating of VITROS® CRP slides, related to lower-than-expected results when testing patient samples known to have elevated concentrations of CRP (>90 mg/l or >9 mg/dl). When tested neat, results were reported as being within the upper end of the measuring range (70-90 mg/l or 7-9 mg/dl) however, upon dilution, results for these samples were reported as having concentrations greater than 2x the neat result. Patient samples with a CRP concentration above 90 mg/l (9 mg/dl) (typically above 150 mg/l (15 mg/dl)) may be reported as falsely reduced when samples are tested neat, with the dilute sample results predicting greater than 2x greater than the neat result. The observed bias will vary; however, the predicted neat CRP results will generally range between 70-90 mg/l (7-9 mg/dl). Recall start date: October 25, 2024
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