Z-0861-2021Class II

Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number...

Name: Z-0861-2021 Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2020-12-02
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-12-02 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the... on 2020-12-02. FDA classified it as Class II and gives the reason as "Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0861-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-02
Posted: 2021-01-14
Terminated: 2024-06-06
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
Product code: JGS Electrode, Ion Specific, Sodium
Reason for recall: Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: Siemens has issued an Urgent Medical Device Correction letter (UMDC ASW21-02.A.US) and Urgent Field Safety Notice, (UFSN ASW21-02.A.OUS) to all affected Customers stating reason for recall, health risk and action to take: Software version 1.24.x correcting the issues will be released when available and all systems will be updated. The following actions must be taken until your system has been updated to software version 1.24 or higher which resolves the issues listed below. Siemens Healthineers will notify you when an updated software version is available. Issue Number 1: Patient sample may be run on analyzer where it was disabled. 1. When reporting results, ensure that the result for the assay that is disabled on one analyzer, came from a system where the assay had not been disabled and all QC results are within the laboratory acceptable range. 2. To check if an assay is enabled or disabled, navigate to Setup/>/Test Definition/>/Assay List/>/CH or IM tab./An assay is/enabled if the box is checked in the column/for an analyzer. 3. The Audit Trail screen (System->Logs->Audit Trail.Log) can be checked to see if an assay had been disabled in the past. Issue Number 2: Bypass mode patient samples may be run. 1. Always ensure that the system covers are properly physically closed and latched. The lock glyph on the System > Status/screen for an analyzer indicates whether the cover is locked or/unlocked. Ensure that there are no yellow unlocked glyphs displayed. 2. Before starting/sample processing,/check/the Operator Event log and ensure that the following error code is not present: 03 600 00 44: A cover is open with the Service Bypass Tools in place. Ensure all operators are clear of moving subassemblies to avoid personal injury or system damage. Corrective Action: Contact the local technical support provider for assistance./ Refer to the online help Alerts section 03 IM Event Troubleshooting if the error code is present. Issue Number
Quantity in commerce: 2405 units
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Peru, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed. Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E. Ukraine, United Kingdom, Uruguay, Vatika City, Vietnam.
Product codes and lots: Software (SW) versions V1.23.2 (SMN 11469032) or lower

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0861-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0861-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-14
Z-0862-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-14
Z-0863-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-14

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)