Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cascadion SM Clinical Analyzer Recalled by Thermo Fisher Scientific Due to Due to software defect, under certain assay parameters,...
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 Thermo Fisher Scientific directly.
Affected Products
Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Quantity: 19 systems (1 system in U.S. and 10 system O.U.S.)
Why Was This Recalled?
Due to software defect, under certain assay parameters, false Vitamin D results may be reported. The system reports a false result by not quantitating the correct analyte peak in sample chromatogram. The resulting sample would show a Vitamin D-concentration that is an unusual situation for human serum and plasma samples and would indicate a severe Vitamin D deficiency.
Where Was This Sold?
U.S.: Texas O.U.S.: Belgium, France, Germany, Italy, Spain, Switzerland and United Kingdom
About Thermo Fisher Scientific
Thermo Fisher Scientific has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report