Siemens Healthcare Diagnostics, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
Lot # 5890128326 and Lot # 182670004 UDI: 00842768012334
Products Sold
Lot # 5890128326 and Lot # 182670004 UDI: 00842768012334
Siemens Healthcare Diagnostics, Inc. is recalling N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins due to Iincreased (falsely elevated) Albumin results compared to expected results. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Iincreased (falsely elevated) Albumin results compared to expected results
Recommended Action
Per FDA guidance
Siemens Healthcare Diagnostics issued Urgent Medical Device Correction (UMDC) letter PP-19-002.A.US to the US customers June 27, 2019 and May 2019 via FedEx overnight delivery and email to regional countries for implementation Outside the US (OUS). Customers were instructed to contact their Siemens Healthineers Customer Care Center for further follow-up in case they experienced sporadically increased Albumin results compared to expected results. Customers were also instructed to complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026