Recall Z-2129-2023— Ortho-Clinical Diagnostics

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2023-05-08. FDA's recall record names no specific 510(k) clearance for this event. Product: VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM. Product Code: 6801704. Reason: Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the highest bias observed in selected sample testing investigation was +35.3% for IgM; -4.3% for IgG; +12.3% for IgA; -6.9% for C3; -6.6% for C4; and -17.8% for transferrin. Falsely elevated or reduced results could be reported depending on the analyte and/or sample concentration..

Recalling firm

Ortho-Clinical Diagnostics

Classification

Class II

Status

Ongoing

Initiated

2023-05-08

Firm location

Rochester, NY, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.