medical Class II Updated 2021-03-17

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

Recalled Product

Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910

Hazard / Issue

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.

Issued by

FDA

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

Lot/Code Info: Model Number 99990000 GTIN: 06438153004925 Serial Numbers: CA100077, CA000055, CA100073, CA100074, CA000051, CA100062, CA100065, CA100069, CA100070 CA100063 CA000042, CA100071 CA100060, CA100059, CA000058, CA000053, CA000056, CA100061, CA100066

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