SIEMENS HEALTHCARE DIAGNOSTICS INC Recall 90867
Description: N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
SIEMENS HEALTHCARE DIAGNOSTICS INC Recall 90867 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0094-2023 |
| Event ID | 90867 |
| Event Description | N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299 |
| Product Type | Devices |
| Distribution | Nationwide |
| Quantity | 10,201 packs |
| Recall Reason | N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF). |
| Device Classification | 20221026 |
| Device Code Info | UDI-DI: 0405686900179VF Lot Number: 153083; 153085; 153087A; 153090; 153095B; 153099A; 153004B. Future lots may be impacted by the issue but will then be provided with a corresponding instruction note within the reagent package |
| Center Classification Date | 20221014 |
| Recall Initiation Date | 20220830 |
| Recalling Firm | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Initial Notification | Letter |
| Similar To |