Device 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
Z-0449-2022
Product summary
- Event
- Event 89160
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,980 units
- Official record key
device-enforcement:Z-0449-2022
Official wording
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
Code information: Software version: V1.25.1 and lower. UDI: 00630414002163
Distribution pattern: 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
Derived failure modes
-
Device software or design
Software (SW) versions V1.25.1 and lower may result in