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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0094-2023
Event ID90867
Event DescriptionN Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
Product TypeDevices
DistributionNationwide
Quantity10,201 packs
Recall ReasonN 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 Classification20221026
Device Code InfoUDI-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 Date20221014
Recall Initiation Date20220830
Recalling FirmSIEMENS HEALTHCARE DIAGNOSTICS INC
Initial Notification Letter
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