Z-0597-2025Class II

Atellica CI Analyzer. Catalog Numbers: 10947347

Name: Z-0597-2025 Atellica CI Analyzer. Catalog Numbers: 10947347
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2024-11-04
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-11-04 / Open, Classified / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CI Analyzer. Catalog Numbers: 10947347 on 2024-11-04. FDA classified it as Class II and gives the reason as "Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displaying that volume is...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0597-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-04
Posted: 2024-12-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CI Analyzer. Catalog Numbers: 10947347.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displaying that volume is remaining. In this case Sodium (Na), Potassium (K) and Chloride (Cl) test results may be falsely elevated. Quality Control materials demonstrate the same behavior.
Root cause tag: software
FDA root cause: Software design
Quantity in commerce: 559 units
Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Bangladesh, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Iraq, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Malaysia, Netherlands, Oman, Pakistan, Paraguay, Peru, Philippines, Portugal, Qatar, Republic Korea, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom Great Britain, Vietnam.
Product codes and lots: UDI-DI Number: 630414229560; Catalog Number: 10947347. Software version 1.28.51

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0597-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0597-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04

Product code JJE

K222116Class IIAtellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc. / cleared 2023-07-13

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)