Skip to content
Recall Observatory FDA recall evidence

Device product

N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299

Z-0094-2023

August 30, 2022

Class II

Product summary

Firm
SIEMENS HEALTHCARE DIAGNOSTICS INC
Event
Event 90867
Status
Ongoing
Classification
Class II
Quantity
10,201 packs
Official record key
device-enforcement:Z-0094-2023

Official wording

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).

Code information: 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

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).