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Thermo Fisher Scientific recalls Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Recalled March 17, 2021 · FDA recall Z-1202-2021 · 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. · FDA Class II
Units
19 systems (1 system in U.S. and 10 system O.U.S.)
Sold at
U.S.: Texas O.U.S.: Belgium, France, Germany, Italy, Spain, Switzerland and United Kingdom
Description
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.
Product
Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Manufacturer(s)
Thermo Fisher Scientific
Made in
Finland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →