Z-0094-2023 Class II Ongoing
FDA device recall Z-0094-2023 was initiated by SIEMENS HEALTHCARE DIAGNOSTICS INC on Aug 30, 2022 and is designated Class II. 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). The recall status is ongoing. Affected quantity: 10,201 packs.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 26, 2022
- Initiation Date
- Aug 30, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,201 packs
Product Description
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).
Distribution Pattern
Nationwide
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0094-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026