Siemens Healthcare Diagnostics, Inc. Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

(1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay Correlation factor; (2) On Board Stability (OBS) Not Updating with Manual Change for Open Channel Assays may continue to use the reagent past its expiration date leading to potential erroneous patient sample results

Recommended Action

Per FDA guidance

Siemens issued Urgent Medical Device Correction (UMDC), ASW22-01.A.US, to US customers by FedEx beginning on November 18th, 2021. An Urgent Field Safety Notice (UFSN), ASW22-01.A.OUS, was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities beginning on 2021/11/18. Letter states reason for recall, health risk and action to take: The following actions must be taken until your system has been updated to a software version which resolves the issues mentioned in Table 2 above. Siemens Healthineers will notify you when an updated software version is available. Issue 1. TDef Parameters reverting to Default Values When saving changes in the Open Channel configuration screen, saving the screen will reset TDef parameter to default settings. To correct this behavior, navigate back to the TDef screen (Setup>Test Definition>CH Test Definition) and ensure that all TDef parameters are correct (refer to Table 3): x Definition Tab (General) x Definition Tab (Measuring Intervals) x Calculation (General) x Calculation (HIL Alert Indices) x Calculation (Assay Comparison Correlation Factor) x Calibration There is no need to go back to the Open Channel configuration screen after the TDef parameters have been confirmed to be correct or corrected. If navigating back to the Open Channel configuration screen and saving, please repeat above steps. Issue 2. On Board Stability (OBS) Not Updating with Manual Changes Issue 1. TDef Parameters reverting to Default Values When saving changes in the Open Channel configuration screen, saving the screen will reset TDef parameter to default settings. To correct this behavior, navigate back to the TDef screen (Setup>Test Definition>CH Test Definition) and ensure that all TDef parameters are correct (refer to Table 3): x Definition Tab (General) x Definition Tab (Measuring Intervals) x Calculation (General) x Calculation (HIL Alert Indices) x Calc