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Terminated

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 Recall Z-0148-2020 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJGS
Date Initiated2019-07-30
Date Terminated2022-06-10
Product Quantity1125 units

Reason for Recall

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

Firm Action

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.

Root Cause

Software design

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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