Z-2341-2019 Class II Terminated
FDA device recall Z-2341-2019 was initiated by Siemens Healthcare Diagnostics, Inc. on June 27, 2019 and is designated Class II. Reason for recall: Iincreased (falsely elevated) Albumin results compared to expected results The recall status is terminated (terminated May 27, 2020). Affected quantity: 664 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2019
- Initiation Date
- June 27, 2019
- Termination Date
- May 27, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 664 units
Product Description
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
Reason for Recall
Iincreased (falsely elevated) Albumin results compared to expected results
Distribution Pattern
Nationwide
Code Information
Lot # 5890128326 and Lot # 182670004 UDI: 00842768012334