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 number

Z-0449-2022

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Product

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

Status

Open, Classified

Initiated

2021-11-18

Posted

not on file

Terminated

not on file

Reason

(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

Root cause

Software design

Action

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

Quantity

2,980 units

Distribution

Nationwide Foreign: AU DE AE TR BG CL IN CZ BR ES KE CN PL SA BE IQ IT CW SE AR CO GR SK EE KR JP UY DK FR GB VN CA BD MX TH DZ PT RU ZA PK HU NL VA NO AT IR LV EG PH SG MY IL FI HR MA KW CH TW BH AL BF UG NZ OM HK QA PE EC IE GP LY LT

Lot, serial or model codes

Software version: V1.25.1 and lower. UDI: 00630414002163

510(k) numbers

["K151767"]

PMA numbers

not on file

Product code

JGS

Firm FEI

2432235

Firm city

Tarrytown

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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