—#177941

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.

FDA product code: JGS — Electrode, Ion Specific, Sodium
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K151767
Affected 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.

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm, Siemens Healthineers, sent an "Urgent Field Safety Notice ASW20-01.A.OUS" dated October, 2019 to its customers. The notice described the product, the problem and the actions to be taken. Actions to be Taken by the Customer 1. Scan the barcodes for IMT system fluids Std A and Std B for Na, K, and Cl at the system workstation using the manual barcode reader. Do not scan these barcodes at the module console. " When available, software v1.20.1 will be delivered as follows: " For systems running software v1.19.0 or higher, the software will be delivered electronically through the Siemens Smart Remote Service (SRS) and a yellow alert: "A new software update is available and is ready to install." will prompt the user to install the software. " For all other system configurations, you will be contacted by your local Siemens Customer Service representative to schedule the software installation. " Please review this letter with your Medical Director. " Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days via email to: ranjan.sandarangani@Siemens-Healthineers.com. " If you have received any complaints of illness or adverse events associated with the product listed in Table1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. If you any further questions, contact Quality Engineer, at 914-631-8000 or email: Ranjan.Sandarangani@Siemens-Healthineers.com.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2019-10-11
Terminated: 2021-05-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177941. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.