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SIEMENS HEALTHCARE DIAGNOSTICS INC recalls N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 104
Recalled October 26, 2022 · FDA recall Z-0094-2023 · SIEMENS HEALTHCARE DIAGNOSTICS
Hazard
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). · FDA Class II
Units
10,201 packs
Sold at
Nationwide
Description
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).
Product
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
Manufacturer(s)
SIEMENS HEALTHCARE DIAGNOSTICS INC
Made in
Spain
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →