Reported Oct 26, 2022 · Ongoing
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN):…
Siemens Healthcare Diagnostics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SIEMENS HEALTHCARE DIAGNOSTICS INC · 511 Benedict Ave · Tarrytown, N/A · N/A
Is this the product you have?
- N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System-
- IVD Siemens Material Number (SMN)10446299
- Lot codes and dates
- UDI-DI0405686900179VF
- Lot Number153083; 153085; 153087A; 153090; 153095B; 153099A; 153004B. Future lots may be impacted by the issue but will then be provided with a corresponding instruction note within the reagent package
- Amount recalled
- 10,201 packs
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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).
This product could cause temporary or reversible health problems — stop using it.
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