N Antiserum to Human IgG — Class II medical device recall Z-0094-2023
Ongoing recall by SIEMENS HEALTHCARE DIAGNOSTICS INC, reported 2022-10-26, distributed nationwide. N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for I
| Recall number | Z-0094-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC, Tarrytown, N/A, Spain |
| Recall initiated | 2022-08-30 |
| Classified | 2022-10-14 |
| Reported by FDA | 2022-10-26 |
| Distributed | Nationwide (US) |
| Quantity | 10,201 packages |
| Lot numbers | 153004B, 153083, 153085, 153087A, 153090, 153095B, 153099A |
Product
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
Reason for 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0094-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.