FDA-Device2022-10-26Class II
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
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).
Sold states
Nationwide
Affected count
10,201 packs
Manufactured in
511 Benedict Ave, N/A, Tarrytown, N/A, Spain
Products
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0094-2023Don't want to check this manually?
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