N Antiserum to Human IgG Fails High-Dose Hook Effect Performance Standards
Siemens N Antiserum to Human IgG reagent batches are not meeting performance standards for high-dose immunoassay testing. The issue affects 10,201 packs distributed nationwide and may result in inaccurate diagnostic test results.
- Product
- N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
- Category
- Medical Device
- Distribution
- Distributed nationwide