VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products FSH Reagent Pack and related LH and Prol Reagents worldwide due to low end imprecision that may cause falsely high or delayed patient and quality control results. The issue affects low-level samples at the low end of the measuring range and involves calibration failures related to imprecision in Calibrator Level 1. A total of 2,502 units have been distributed (2,154 in the US and 348 outside the US) across multiple countries including Australia, Brazil, Canada, China, Japan, the United Kingdom, and others, with affected lot numbers ranging from 3100 (expiring March 1, 2022) through 3210 (expiring September 12, 2022). Future lots are also expected to be affected until further notice.
The recall notice does not specify a remedy or recommended 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: 2502 total: 2154 US; 348 OUS Lot/code info: Until further notice, future lots will also be affected. UDI: 10758750000302 Affected Lot Number/ Expiration Date: 3100 01-MAR-2022; 3111 25-MAR-2022; 3120 04-APR-2022; 3130 25-APR-2022; 3140 10-MAY-2022; 3145 10-MAY-2022; 3150 30-MAY-2022; 3160 09-JUN-2022; 3170 22-JUN-2022; 3180 02-AUG-2022; 3190 16-AUG-2022; 3200 06-SEP-2022; 3210 12-SEP-2022.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.