# FDA recall Z-0093-2023

> **SIEMENS HEALTHCARE DIAGNOSTICS INC** · Class II · device recall initiated 2022-08-30.

## Product

N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD  Siemens Material Number (SMN): 10446297

## 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).

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0093-2023
- **Recalling firm:** SIEMENS HEALTHCARE DIAGNOSTICS INC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-30
- **Report date:** 2022-10-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, N/A, Spain

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0093-2023

## Citation

> AI Analytics. FDA recall Z-0093-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0093-2023. Source: US FDA. Licensed CC0.

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