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Siemens Healthcare Diagnostics, Inc. recalls Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
Recalled May 6, 2020 · FDA recall Z-1797-2020 · Siemens Healthcare Diagnostics
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. · FDA Class II
Units
1807
Sold at
US Nationwide. Global distribution.
Description
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.
Product
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →