Atellica CI Analyzer (Siemens) – Diluent Volume Issue (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Atellica CI Analyzer. Catalog Numbers: 10947347.
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
UDI-DI Number: 630414229560, Catalog Number: 10947347. Software version 1.28.51
Products Sold
UDI-DI Number: 630414229560; Catalog Number: 10947347. Software version 1.28.51
Siemens Healthcare Diagnostics, Inc. is recalling Atellica CI Analyzer. Catalog Numbers: 10947347. due to Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IM. Based on FDA medical device recall database.
Summary derived from FDA notice
The following details were not provided by the FDA: corrective action details.
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026