medical Class II Updated 2022-01-12

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH 930 Analyzer with Software version: V1.25.1 and

Recalled 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


Hazard / Issue

(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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software version: V1.25.1 and lower. UDI: 00630414002163
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →