Recall Z-2341-2019 ยท JZW Nephelometer
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
| Date | Jun 27, 2019 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001647 | BN PROSPEC SYSTEM Dade Behring, Inc., Sep 26, 2000 |