FDA-Device2021-03-17Class II
Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Thermo Fisher Scientific
Hazard
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.
Sold states
U.S.: Texas O.U.S.: Belgium, France, Germany, Italy, Spain, Switzerland and United Kingdom
Affected count
19 systems (1 system in U.S. and 10 system O.U.S.)
Manufactured in
Ratashe 2, Vantaa, Finland
Products
Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1202-2021Don't want to check this manually?
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