VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Immunodiagnostic Products LH Reagent Pack and related FSH and Prol Reagents due to low end imprecision that can cause falsely high or delayed results in patient and quality control samples at the low end of the measuring range. The imprecision stems from calibration failures driven by issues with Calibrator Level 1. A total of 1,575 units have been distributed worldwide, including 1,183 units in the US and 392 units internationally across countries including Australia, Canada, China, France, Germany, Japan, Mexico, the United Kingdom, and others. The affected lot numbers range from 1910 through 1960 with expiration dates between August 2022 and January 2023, and the company has indicated that future lots will also be affected until further notice.
The recall notice does not specify a remedy or instructions for what affected consumers or healthcare facilities should do regarding the recalled reagent packs.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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 Quantity: 1575 units total: 1183 US; 392 OUS 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.