FDA recall Z-0094-2023

SIEMENS HEALTHCARE DIAGNOSTICS INC · Class II · device

Product

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

Reason for recall

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).

Distribution

Nationwide

Key facts

Status: Ongoing
Initiation date: 2022-08-30
Report date: 2022-10-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tarrytown, N/A, Spain

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0094-2023