Z-0862-2020Class II

Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica...

Name: Z-0862-2020 Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2019-10-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-10-11 / Terminated / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on 2019-10-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0862-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-11
Posted: 2020-01-24
Terminated: 2021-05-03
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JGS Electrode, Ion Specific, Sodium
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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: [email protected]. " 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: [email protected].
Quantity in commerce: 1528
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0862-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0862-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24

Product code JGS

K151767Class IITrinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP CalibratorSiemens Healthcare Diagnostics, Inc. / cleared 2015-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)