—#174672

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

FDA product code: JZW — Nephelometer
Device class: Class 1
Medical specialty: Immunology
510(k) numbers: K001647
Affected lot / code info: Lot # 5890128326 and Lot # 182670004 UDI: 00842768012334

Why it was recalled

Iincreased (falsely elevated) Albumin results compared to expected results

Root cause (FDA determination)

Process change control

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2019-06-27
Terminated: 2020-05-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #174672. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.