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Ortho-Clinical Diagnostics, Inc Recall 90047

Description: VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198

Ortho-Clinical Diagnostics, Inc Recall 90047 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1113-2022
Event ID90047
Event DescriptionVITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
Product TypeDevices
DistributionWorldwide 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
Quantity1575 units total: 1183 US; 392 OUS
Recall ReasonFalsely 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.
Device Classification20220525
Device Code InfoUntil 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
Center Classification Date20220518
Recall Initiation Date20220325
Recalling FirmOrtho-Clinical Diagnostics, Inc
Initial Notification Letter
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