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Siemens Healthcare Diagnostics, Inc. recalls Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930
Recalled February 5, 2020 · FDA recall Z-0862-2020 · Siemens Healthcare Diagnostics
Hazard
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. · FDA Class II
Units
1528
Sold at
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.
Description
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.
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(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →