Cascadion SM Clinical Analyzer — Class II medical device recall Z-1202-2021
Terminated recall by Thermo Fisher Scientific, reported 2021-03-17, distributed in TX. Due to software defect, under certain assay parameters, false Vitamin D results may be reported. The system re
| Recall number | Z-1202-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thermo Fisher Scientific, Vantaa, Finland |
| Recall initiated | 2021-02-01 |
| Classified | 2021-03-10 |
| Reported by FDA | 2021-03-17 |
| Terminated | 2024-01-10 |
| Distributed | TX |
| Countries outside the US | BE, CH, DE, ES, FR, GB, IT |
| Reason classes | potency, software |
| Serial numbers | CA000042, CA000051, CA000053, CA000055, CA000056, CA000058, CA100059, CA100060, CA100061, CA100062, CA100063, CA100065, CA100066, CA100069, CA100070, CA100071, CA100073, CA100074, CA100077 |
| Model numbers | 99990000 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1202-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.