medical Class II Updated 2022-05-25

Ortho-Clinical Diagnostics, Inc recalls VITROS Immunodiagnostic Products Prolactin Reagent Pack

Recalled Product

VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793

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: 10758750000111 Affected Lot Number/ Expiration Date: 2840 13-MAY-2022; 2850 08-JUN-2022; 2860 02-JUL-2022; 2870 17-JUL-2022; 2875 17-JUL-2022; 2880 14-SEP-2022; 2891 28-SEP-2022; 2900 29-OCT-2022;

View official government recall

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