medical Class II Updated 2024-12-11

Siemens Healthcare Diagnostics, Inc. recalls Atellica CI Analyzer. Catalog Numbers: 10947347.

Recalled Product

Atellica CI Analyzer. Catalog Numbers: 10947347.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI Number: 630414229560; Catalog Number: 10947347. Software version 1.28.51
View official government recall

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