—#175626

Product

Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens

FDA product code: JGS — Electrode, Ion Specific, Sodium
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K151767
Affected lot / code info: Software version: V1.19.2 and below

Why it was recalled

Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below

Root cause (FDA determination)

Software design

Action the firm took

Siemens issued an Urgent medical Device Correction, (UMDC ASI19-02.A.US) via Fed Ex and Urgent Field Safety Notification (UFSN ASI19-02.A.OUS) to all affected Customers beginning on 2019-07-30. The UFSN/UMDC explain the behaviors that can occur and instructs customers on actions to be taken for the issues described in the communication. Customers are requested to return the attached effectiveness check form via fax or email within 30 days. Field Service personnel will be sent a Service Knowledge Base describing the issue and instructing them how to deal with customer questions.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide Foreign: Argentina Australia Austria Bangladesh Belgium Brazil Bulgaria Canada Chile Colombia Czech Republic Denmark Ecuador Egypt Finland France Germany Greece Hungary India Indonesia Iran Ireland Israel Italy Japan Kuwait Latvia Malaysia Mexico Netherlands Nigeria Norway P.R. China Pakistan Philippines Poland Portugal Qatar Republic Korea Romania Russian Fed. Saudi Arabia Singapore Slovakia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. United Kingdom Uruguay Vietnam

Timeline

Recall initiated: 2019-07-30
Terminated: 2022-06-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175626. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.