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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica CH Iron3 (Iron3)

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  Class 2 Device Recall Atellica CH Iron3 (Iron3) see related information
Date Initiated by Firm March 13, 2024
Date Posted April 16, 2024
Recall Status1 Open3, Classified
Recall Number Z-1549-2024
Recall Event ID 94260
Product Classification Photometric method, iron (non-heme) - Product Code JIY
Product Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using the Atellica¿ CI Analyzer and Atellica¿ CH Analyzer
Siemens Material Number (SMN): 11537211
Code Information UDI-DI: 00630414610849 All lots
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact SAME
914-631-8000
Manufacturer Reason
for Recall		 Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Results in a positive bias ranging from 2-16% -impacts calibrator, quality control (QC), and patient results.
FDA Determined
Cause 2		 Device Design
Action Siemens issued Urgent Medical Device Correction (UMDC) ACHC24-03.A.US to US customers via FedEx beginning on 03/13/2024. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities beginning on 03/13/2024. New customers who purchase the Atellica CH Iron3 assay on the Atellica CH and Atellica CI analyzers will receive the UMDC/UFSN, until the product issue is resolved. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Refer to short-term mitigation steps in Appendix B while Siemens works towards transitioning customers back to the Iron_2 assay. {The UMDC/UFSN provides instructions to Atellica Solutions customers with multiple analyzers to segregate Iron3 and the impacted assays (Chol_2, LDLC, and Trig_2) onto separate systems. Atellica Solutions customers with a single Atellica analyzer instructed to stop use of Iron3 and identify alternative methods for Iron testing]. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Resolution Siemens is actively working to ramp up the supply volume to support customer conversion to the Iron_2 assay. We anticipate being able to support an end to the mitigation within a six month timeframe. A follow up communication will be provided when Customer Actions are no longer required. These mitigations will remain in effect until the solution is provided
Quantity in Commerce 8721 units
Distribution Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Curacao, St¿Eus, Czech Republic, Denmark, Estonia, Finland, France, Germany, ¿ Greece, Hungary, India, Ireland, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, ¿¿¿¿ New Zealand, Norway, Paraguay, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., United¿Kingdom.¿
Total Product Life Cycle TPLC 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.
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