Siemens Atellica CH 930 Analyzer Recall for Software Defect
Siemens is recalling Atellica CH 930 Analyzers with specific software versions due to a defect that may cause incorrect test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential incorrect test results without reported injuries or hospitalizations, fitting the criteria for moderate severity.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,807 units of the Atellica CH 930 Analyzer, Siemens Material Number 11067000, equipped with software version v1.21.0 SP1 or lower. The recall covers units distributed in the United States and globally.
The recall is issued because editing an assay Test Definition and switching to another assay's Test Definition screen without saving the changes may corrupt the settings of the assay's test definition. This corruption can cause Auto-Rerun or Auto-Dilution results to generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.
Healthcare facilities and laboratories using these analyzers should contact Siemens Healthcare Diagnostics for instructions on how to resolve the software issue.
The recalled product
- Product
- Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,807
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 00630414002163
Distribution
Distributed nationwide across the United States.
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