Siemens Healthcare recalls N Antiserum to Human IgG (SMN 10446297) due to potential inaccurate test results. Affected units may not meet expected concentration levels for urine and CSF tests.
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).
Siemens Healthcare is recalling N Antiserum to Human IgG for BN II and BN ProSpec systems because the product may not provide accurate test results at expected concentrations. This could lead to incorrect medical diagnoses if used in urine and CSF testing.
The N Antiserum to Human IgG may not meet the required concentration levels for urine (up to 648 mg/L) and CSF (up to 2290 mg/L) tests. This could cause inaccurate test results, potentially leading to incorrect medical diagnoses.
Healthcare professionals using Siemens N Antiserum to Human IgG for urine and CSF tests. Patients receiving tests with this reagent may be at risk of inaccurate results.
Check for Siemens Material Number (SMN) 10446297 on the product. The product was sold with UDI-DI 0405686900179VF and Lot Number 153088. Future lots will have instructions in the reagent package.
Look for Siemens Material Number (SMN) 10446297 on the product label.
The product may not provide accurate test results, but it does not pose a direct safety risk to users. Inaccurate results could affect medical diagnoses.
Check the product label for Siemens Material Number (SMN) 10446297. If you have the affected lot, contact Siemens Healthcare for instructions.
Future lots will have instructions in the reagent package to address the issue.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0093-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0093-2023 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
