Siemens Healthcare recalls N Antiserum to Human IgG for BN II and BN ProSpec systems due to potential inaccurate test results in urine and CSF samples. Affected lots may not meet required concentration levels.
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 meet the required concentration levels for accurate urine and CSF tests. This could lead to incorrect test results if used as intended.
The N Antiserum to Human IgG may not meet the required concentration levels (up to 648 mg/L for urine and 2290 mg/L for CSF) as specified by the manufacturer. This could cause inaccurate test results when used in the BN II and BN ProSpec systems.
Healthcare professionals using Siemens' N Antiserum to Human IgG for urine and CSF testing are affected. Those testing for specific conditions using these reagents may be at risk of inaccurate results.
Check for Siemens Material Number (SMN) 10446299 on the reagent label. Affected lots include 153083, 153085, 153087A, 153090, 153095B, 153099A, and 153004B. Future lots will have instructions if impacted.
Look for lot numbers 153083, 153085, 153087A, 153090, 153095B, 153099A, or 153004B on the reagent label.
The N Antiserum to Human IgG may not meet the required concentration levels for accurate urine and CSF tests as specified by the manufacturer.
Check the lot number on the reagent label. If it matches the affected lots listed, contact Siemens Healthcare for instructions.
Future lots may be impacted but will include instructions in the reagent package if the issue persists.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0094-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0094-2023 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.
