Device product
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
Z-0093-2023
Product summary
- Event
- Event 90867
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 373 PCK
- Official record key
device-enforcement:Z-0093-2023
Official wording
Reason: 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).
Code information: UDI-DI: 0405686900179VF Lot Number: 153088 Future lots may be impacted by the issue but will then be provided with a corresponding instruction note within the reagent package
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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).