N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
Reported: October 26, 2022 Initiated: August 30, 2022 #Z-0094-2023
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).
Details
- Recalling Firm
- SIEMENS HEALTHCARE DIAGNOSTICS INC
- Units Affected
- 10,201 packs
- Distribution
- Nationwide
- Location
- Tarrytown, N/A
Frequently Asked Questions
What product was recalled? ▼
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299. Recalled by SIEMENS HEALTHCARE DIAGNOSTICS INC. Units affected: 10,201 packs.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 26, 2022. Severity: Moderate. Recall number: Z-0094-2023.
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