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 |
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