FDA-Device2020-05-06Class II
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
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-1797-2020More Siemens Healthcare Diagnostics, Inc. recalls
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