FDA Medical Device Recalls (openFDA)
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 number
- Z-2341-2019
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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
- Status
- Terminated
- Initiated
- 2019-06-27
- Posted
- not on file
- Terminated
- 2020-05-27
- Reason
- Iincreased (falsely elevated) Albumin results compared to expected results
- Root cause
- Process change control
- Action
- 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.
- Quantity
- 664 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot # 5890128326 and Lot # 182670004 UDI: 00842768012334
- 510(k) numbers
- ["K001647"]
- PMA numbers
- not on file
- Product code
- JZW
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28