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Ortho-Clinical Diagnostics, Inc recalls VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
Recalled May 25, 2022 · FDA recall Z-1114-2022 · Ortho-Clinical Diagnostics
Hazard
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. · FDA Class II
Units
1767 units total: 1521 US; 246 OUS
Sold at
Worldwide Distribution: US (Nationwide) OUS (Foreign): Australia Bermuda Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Netherlands Norway Portugal Russia Singapore Spain Sweden United Kingdom
Description
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.
Product
VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
Manufacturer(s)
Ortho-Clinical Diagnostics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →