Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (li...
FDA Recall #Z-1549-2024 — Class II — March 13, 2024
Product Description
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
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.
Recalling Firm
Siemens Healthcare Diagnostics, Inc. — Tarrytown, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product 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, 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.¿
Code Information
UDI-DI: 00630414610849 All lots
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated