Z-0449-2022Class II

Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer...

Name: Z-0449-2022 Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2021-11-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-11-18 / Open, Classified / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on 2021-11-18. FDA classified it as Class II and gives the reason as "(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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0449-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-18
Posted: 2022-01-03
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
Product code: JGS Electrode, Ion Specific, Sodium
Reason for recall: (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 tag: software
FDA 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 in commerce: 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
Product codes and lots: Software version: V1.25.1 and lower. UDI: 00630414002163

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0449-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0449-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-12	2022-01-03

Product code JGS

K151767Class IITrinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP CalibratorSiemens Healthcare Diagnostics, Inc. / cleared 2015-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)