medical Class II Updated 2022-05-25

Ortho-Clinical Diagnostics, Inc recalls VITROS Immunodiagnostic Products LH Reagent Pack Product Co

Recalled Product

VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198

Hazard / Issue

Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. 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. Calibration failures, driven by imprecision observed with Calibrator Level 1.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Until further notice, future lots will also be affected. UDI: 10758750008902 Affected Lot Number/ Expiration Date: 1910 14-AUG-2022 1920 19-SEP-2022 1930 19-OCT-2022 1940 31-OCT-2022 1950 28-JAN-2023 1960 31-JAN-2023
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