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Ortho-Clinical Diagnostics, Inc Recall 90047

Description: VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922

Ortho-Clinical Diagnostics, Inc Recall 90047 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1112-2022
Event ID90047
Event DescriptionVITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
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
Quantity2502 total: 2154 US; 348 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: 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.
Center Classification Date20220518
Recall Initiation Date20220325
Recalling FirmOrtho-Clinical Diagnostics, Inc
Initial Notification Letter
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