# FDA recall Z-1202-2021

> **Thermo Fisher Scientific** · Class II · device recall initiated 2021-02-01.

## 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.

## Distribution

U.S.: Texas    O.U.S.: Belgium, France, Germany, Italy, Spain, Switzerland and United Kingdom

## Key facts

- **Recall number:** Z-1202-2021
- **Recalling firm:** Thermo Fisher Scientific
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-01
- **Report date:** 2021-03-17
- **Termination date:** 2024-01-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Vantaa, Finland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1202-2021

## Citation

> AI Analytics. FDA recall Z-1202-2021. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1202-2021. Source: US FDA. Licensed CC0.

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