Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
N Antiserum to Human IgG Recalled by SIEMENS HEALTHCARE DIAGNOSTICS INC Due to N Antiserum to Human IgG are not meeting...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SIEMENS HEALTHCARE DIAGNOSTICS INC directly.
Affected Products
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
Quantity: 10,201 packs
Why Was This Recalled?
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).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SIEMENS HEALTHCARE DIAGNOSTICS INC
SIEMENS HEALTHCARE DIAGNOSTICS INC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report