Siemens Healthcare N Antiserum to Human IgG Recall: Inaccurate Test Results
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.
Lower-risk recall
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).
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/60109-siemens-healthcare-n-antiserum-to-human-igg-recall-inaccurate-test.
Source Summary by GovInfoNow · govinfonow.com/recall/60109-siemens-healthcare-n-antiserum-to-human-igg-recall-inaccurate-test · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0093-2023
Cite this page
“Siemens Healthcare N Antiserum to Human IgG Recall: Inaccurate Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60109-siemens-healthcare-n-antiserum-to-human-igg-recall-inaccurate-test. Based on FDA recall #Z-0093-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0093-2023%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Siemens Healthcare- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0093-2023 | N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297; UDI-DI: 0405686900179VF Lot Number: 153088 Future lots may be impacted by the issue but will then be provided with a corresponding instruction note within the reagent package | 373 PCK |
| Z-0094-2023 | N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299; UDI-DI: 0405686900179VF Lot Number: 153083; 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 | 10,201 packs |
What to do — step by step
Check Product Details
Look for Siemens Material Number (SMN) 10446297 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 57 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0093-2023 (August 30, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0093-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.