Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for Recalled by Siemens Healthcare Diagnostics, Inc. Due to Bilirubin assays may exhibit a positive bias with...
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
Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: Dimension TBI method for the ¿ clinical chemistry syst6em is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma. Dimension Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder disease.
Quantity: 1639 US and 747 OUS
Why Was This Recalled?
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
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