Device product
N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539
Z-2341-2019
Product summary
- Event
- Event 83311
- Status
- Terminated
- Classification
- Class II
- Quantity
- 664 units
- Official record key
device-enforcement:Z-2341-2019
Official wording
Reason: Iincreased (falsely elevated) Albumin results compared to expected results
Code information: Lot # 5890128326 and Lot # 182670004 UDI: 00842768012334
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Iincreased (falsely elevated) Albumin results compared to expected results