Company: Thermo Fisher Scientific
Date of Enforcement Report: 3/17/2021
Class II

PRODUCT

Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910

Recall Number: Z-1202-2021

REASON

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.

RECALLING FIRM/MANUFACTURER

Thermo Fisher Scientific on 2/1/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

19 systems (1 system in U.S. and 10 system O.U.S.)

DISTRIBUTION

U.S. Nationwide and International