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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica CI Analyzer

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 Class 2 Device Recall Atellica CI Analyzersee related information
Date Initiated by FirmNovember 04, 2024
Date PostedDecember 04, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0597-2025
Recall Event ID 95644
510(K)NumberK222116 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductAtellica CI Analyzer. Catalog Numbers: 10947347.
Code Information UDI-DI Number: 630414229560; Catalog Number: 10947347. Software version 1.28.51
FEI Number 2432235
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information ContactKarl Aebig
914-255-0572
Manufacturer 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.
FDA Determined
Cause 2		Software design
Quantity in Commerce559 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JJE
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