Thermo Fisher Scientific recalls Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910

Recall date

February 1, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1202-2021

FDA classification

Class II

Brand / firm

Thermo Fisher Scientific

Sold / distributed

U.S.: Texas O.U.S.: Belgium, France, Germany, Italy, Spain, Switzerland and United Kingdom

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910