Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in Recalled by Siemens Healthcare Diagnostics, Inc. Due to Fructosamine QC and patient samples may exhibit a...
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 Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 11097637
Quantity: US: 28; OUS: 255 units
Why Was This Recalled?
Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.
Where Was This Sold?
This product was distributed to 7 states: CA, DE, MD, NJ, NY, NC, PA
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