Ortho-Clinical Diagnostics, Inc. Recall 92485
Description: VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090
Ortho-Clinical Diagnostics, Inc. Recall 92485 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2225-2023 |
| Event ID | 92485 |
| Event Description | VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of CA. |
| Quantity | 2 units |
| Recall Reason | May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU). |
| Device Classification | 20230802 |
| Device Code Info | UDI-DI: 10758750033324 Lot # 0090, Expiration Date: 19-Jun-2023 |
| Center Classification Date | 20230721 |
| Recall Initiation Date | 20230518 |
| Recalling Firm | Ortho-Clinical Diagnostics, Inc. |
| Initial Notification | Letter |
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