Ortho-Clinical Diagnostics, Inc Recall 90047
Description: VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Ortho-Clinical Diagnostics, Inc Recall 90047 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1112-2022 |
| Event ID | 90047 |
| Event Description | VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922 |
| Product Type | Devices |
| 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 |
| Recall Reason | 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. |
| Device Classification | 20220525 |
| Device 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. |
| Center Classification Date | 20220518 |
| Recall Initiation Date | 20220325 |
| Recalling Firm | Ortho-Clinical Diagnostics, Inc |
| Initial Notification | Letter |
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