Siemens Healthcare Diagnostics, Inc.: 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.

Recall number

Z-0861-2021

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.

Status

Terminated

Initiated

2020-12-02

Posted

not on file

Terminated

2024-06-06

Reason

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

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

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.

Lot, serial or model codes

Software (SW) versions V1.23.2 (SMN 11469032) or lower

510(k) numbers

["K151767"]

PMA numbers

not on file

Product code

JGS

Firm FEI

2432235

Firm city

Tarrytown

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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