Recall Z-1549-2024 · JIY Photometric Method, Iron (Non-Heme)
Siemens Healthcare Diagnostics, Inc.
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
| Date | Apr 16, 2024 (initiated Mar 13, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.