Drug recall
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number…
FDA recall event 90867 · Class II · SIEMENS HEALTHCARE DIAGNOSTICS INC
Key facts
| Event ID | 90867 |
|---|---|
| Recall numbers | Z-0093-2023, Z-0094-2023 |
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Product type | Devices |
| Products | N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297, N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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). |
| Initiation date | Aug 30, 2022 |
| Report date | Oct 26, 2022 |
| City | Tarrytown |
| Country | Spain |
| FEI number | 3014838736 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: