—#189522

Product

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543

FDA product code: CEK — Biuret (Colorimetric), Total Protein
Device class: Class 2
Medical specialty: Clinical Chemistry
Affected lot / code info: All lots impacted

Why it was recalled

The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.

Root cause (FDA determination)

Software design

Action the firm took

On September 20, 2021, the firm distributed Urgent Medical Device Correction letters to impacted customers. Atellica customers were informed that the resolution of the issue will be implemented in SW v1.25.1. ADVIA customers were informed that the resolution of the issue will be implemented in AP Tool v1.11 and TDef v.1.07. These updates will be available soon. In the interim, customers were provided additional instructions to work around the issue until the update is available. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution.

Timeline

Recall initiated: 2021-09-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #189522. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.