Siemens Atellica CH 930 Analyzer Recalled for Barcode Scanning Error
Siemens is recalling 1,528 Atellica CH 930 Analyzers in 17 foreign countries because a barcode scanning error causes the system to use default values instead of specific fluid concentrations for Sodium, Potassium, and Chloride tests.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard involves potential diagnostic errors due to software logic, which fits the Moderate severity criteria for a Class II device recall without reported injuries.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,528 units of the Atellica CH 930 Analyzer, an automated clinical chemistry analyzer used for in vitro diagnostic tests. The recall affects units with Siemens Material Number 11067000 and Software Versions V1.19.2 or 1.20.0. The affected products were distributed to Argentina, Belgium, Brazil, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, and Vietnam. No affected products were distributed in the United States.
The recall is due to a software error that occurs when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids used in Sodium (Na), Potassium (K), and Chloride (Cl) tests. In countries that use a comma as a decimal separator, the system incorrectly translates decimal point separators to commas. This results in invalid concentration values for the fluids. Consequently, the system utilizes default nominal values instead of the lot-specific IMT fluid concentration values for calculating calibrations and test results.
This issue may lead to inaccurate test results for the affected methods. Siemens is the recalling firm. Users should contact Siemens Healthcare Diagnostics, Inc. for further instructions on how to resolve the issue.
The recalled product
- Product
- Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,528
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 (3)
- UDI: 00630414002163
- 02 vs 1.02)
- AND when scanning barcodes at the module console.
Distribution
Distribution scope not specified by the agency.
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