Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use Recalled by Siemens Healthcare Diagnostics, Inc. Due to Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc. directly.
Affected Products
Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
Quantity: 1614 units US ; 7,979 units OUS
Why Was This Recalled?
Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report