Recall Z-1295-2021— Ortho-Clinical Diagnostics, Inc.

Class II FDA medical device recall by Ortho-Clinical Diagnostics, Inc., initiated 2021-02-18, terminated 2022-10-18. FDA's recall record names no specific 510(k) clearance for this event. Product: VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668 Impacted Products: A. VITROS Chemistry Products TIBC Kit Product No: 7541 (UDI 8750005178) All current and new lots B. VITROS Chemistry Products Fe Slides Product No: 1924547 90 Slides (UDI 10758750000289) Product No: 1515808 300 slides (UDI 10758750009244) Product No: 6802198 (Japan) 90 Slides (UDI 10758750002276) All current, new and previous lots. Reason: Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26), the potential shift in TIBC patient values of GEN 26 and above will be approximately 80 ug/dL lower across the measuring range than other available GENS of VITROS Fe Slides (GENs 22-25)..

Recalling firm

Ortho-Clinical Diagnostics, Inc.

Classification

Class II

Status

Terminated

Initiated

2021-02-18

Terminated

2022-10-18

Firm location

Rochester, NY, United States

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