Class II — Thermo Fisher Scientific
| Recalling firm | THERMO FISHER SCIENTIFIC INC. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910 |
| Quantity | 19 systems (1 system in U.S. and 10 system O.U.S.) |
| Distribution | U.S.: Texas O.U.S.: Belgium, France, Germany, Italy, Spain, Switzerland and United Kingdom |
| Initiated | 2021-02-01 |
| Classified | 2021-03-10 |
| Terminated | 2024-01-10 |
| Recall number | Z-1202-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Thermo Fisher Scientific (Z-1202-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87309/
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