Ortho-Clinical Diagnostics, Inc Recall 90047
Description: VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
Ortho-Clinical Diagnostics, Inc Recall 90047 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1113-2022 |
| Event ID | 90047 |
| Event Description | VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198 |
| 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 | 1575 units total: 1183 US; 392 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: 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 Date | 20220518 |
| Recall Initiation Date | 20220325 |
| Recalling Firm | Ortho-Clinical Diagnostics, Inc |
| Initial Notification | Letter |
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