FDA-Device2020-05-06Class II
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
Siemens Healthcare Diagnostics, Inc.
Hazard
Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.
Sold states
US Nationwide. Global distribution.
Affected count
1807
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1797-2020Don't want to check this manually?
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