Home / Recalls / Thermo Fisher Scientific / Z-1202-2021

Z-1202-2021 Class II Terminated

Recalled by Thermo Fisher Scientific — Vantaa

Recall Details

Product Type: Devices
Report Date: March 17, 2021
Initiation Date: February 1, 2021
Termination Date: January 10, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 19 systems (1 system in U.S. and 10 system O.U.S.)

Product Description

Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910

Reason for Recall

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.

Distribution Pattern

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

Code Information

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