Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0094-2023 — N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299

U.S. FDA — Device Enforcement · Spain · 2022-08-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0094-2023
Date of alert
2022-08-30
Country / jurisdiction
Spain
Risk level
Class II
Risk type
recall
Brand
SIEMENS HEALTHCARE DIAGNOSTICS INC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10446299
Reported risk: 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).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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