Recall Z-1202-2021— Thermo Fisher Scientific
Class II · Terminated
Class II FDA medical device recall by Thermo Fisher Scientific, initiated 2021-02-01, terminated 2024-01-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910. 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
- Thermo Fisher Scientific
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-02-01
- Terminated
- 2024-01-10
- Firm location
- Vantaa, Finland
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.