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