Siemens Healthcare Diagnostics, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
Software version: V1.19.2 and below
Products Sold
Software version: V1.19.2 and below
Siemens Healthcare Diagnostics, Inc. is recalling Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: auto due to Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026