VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Immunodiagnostic Products Prolactin Reagent Pack (Product Code: 1849793) due to low end imprecision that may cause falsely high or delayed patient and quality control results. The imprecision affects low-level samples at the low end of the measuring range and is driven by imprecision in Calibrator Level 1, which can also cause calibration failures. A total of 1,767 units have been distributed worldwide, including 1,521 units in the United States and 246 units internationally across countries including Australia, Canada, China, Japan, the United Kingdom, and others. The affected lot numbers range from 2840 (expiring May 13, 2022) through 2900 (expiring October 29, 2022), and future lots are also affected until further notice.
The recall notice does not specify a remedy or recommended course of action for affected consumers.
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: 1767 units total: 1521 US; 246 OUS 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;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.