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.
Check against the official notice below — it lists the full affected range.
The Siemens Atellica CH 930 Analyzer has a software issue affecting certain units with software versions V1.19.2 or 1.20.0 in countries that use commas instead of decimal points. When barcodes for calibration fluids used in sodium, potassium, and chloride testing are scanned at the module console, the system incorrectly converts decimal point separators to commas, causing invalid concentration values to be read. Because of this error, the analyzer uses default values instead of the correct lot-specific fluid concentrations when calculating calibrations and test results for these three methods.
A total of 1,528 affected analyzers were distributed internationally to countries including France, Germany, Italy, Spain, Brazil, and others. No affected products were distributed in the United States. The source document does not specify a remedy or actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) for Sodium (Na), Potassium (K), and Chloride (Cl), the system will translate the decimal point separators to commas. This will result in invalid concentration values for the fluids, therefore the system will utilize default nominal values instead of lot specific IMT fluid concentration values for calculation of the calibrations and results for the Na, K, and Cl methods.
Reason for recall: On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) for Sodium (Na), Potassium (K), and Chloride (Cl), the system will translate the decimal point separators to commas. This will result in invalid concentration values for the fluids, therefore the system will utilize default nominal values instead of lot specific IMT fluid concentration values for calculation of the calibrations and results for the Na, K, and Cl methods. Distribution: The products were distributed to the following foreign countries: Argentina, Belgium, Brazil, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, and Vietnam. No affected products distributed in the United States. Quantity: 1528 Lot/code info: UDI: 00630414002163, Software Versions V1.19.2 or 1.20.0 when used with languages (countries) that use a comma delimiter instead of a decimal separator (i.e. 1,02 vs 1.02), AND when scanning barcodes at the module console.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.