FDA Device recall Z-1202-2021
Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
- FDA Device
- Class II
- terminated
- Published 2021-03-17
On 2021-03-17 the FDA classified a Class II recall of Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910 by Thermo Fisher Scientific, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1202-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-01 |
| Published | 2021-03-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Thermo Fisher Scientific |
| Distribution | TX |
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.
Identifiers
| code_info | Model Number 99990000 GTIN: 06438153004925 Serial Numbers: CA100077, CA000055, CA100073, CA100074, CA000051, CA…Model Number 99990000 GTIN: 06438153004925 Serial Numbers: CA100077, CA000055, CA100073, CA100074, CA000051, CA100062, CA100065, CA100069, CA100070 CA100063 CA000042, CA100071 CA100060, CA100059, CA000058, CA000053, CA000056, CA100061, CA100066 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1202-2021%22
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