Lower riskMedical device recall · FDA · Published February 1, 2021
Thermo Fisher Cascadion SM Clinical Analyzer Recall: False Vitamin D Results Risk
Thermo Fisher recalls Cascadion SM Clinical Analyzer (SN 9910) due to software defect causing false Vitamin D results. Affected units may indicate severe Vitamin D deficiency. No remedy specified in recall notice.
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.
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Contact the company
📍Recalling firmThermo Fisher ScientificRatashe 2 · Vantaa, Finland
✎ GovInfoNow plain-language explainer
Thermo Fisher is recalling specific models of the Cascadion SM Clinical Analyzer because a software defect can cause false Vitamin D results. This may lead to incorrect health assessments and indicate severe Vitamin D deficiency in patients. The recall affects only certain units with specific serial numbers. Read more at govinfonow.com/recall/63326-thermo-fisher-cascadion-sm-clinical-analyzer-recall-false-vitamin-d.
“Thermo Fisher Cascadion SM Clinical Analyzer Recall: False Vitamin D Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63326-thermo-fisher-cascadion-sm-clinical-analyzer-recall-false-vitamin-d. Based on FDA recall #Z-1202-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1202-2021%22&limit=1).
The FDA announced on Feb. 1, 2021, that Thermo Fisher Scientific voluntarily recalled Cascadion SM Clinical Analyzers due to a software defect that may report false Vitamin D results indicating severe deficiency. The agency issued recall number Z-1202-2021 for the Class II device.
How to tell if you have it
Brand: Thermo Fisher
Product: Cascadion SM Clinical Analyzer, REF 99990000
Due to a software defect under certain assay parameters, the system may not quantitate the correct analyte peak in sample chromatograms. This results in false Vitamin D concentrations that indicate a severe deficiency, an unusual situation for human serum and plasma samples.
Context
GovInfoNow's records show other recent recalls of similar products include Vivoo Test Strips Recall (2025-11-22), Beckman Coulter Access Total T4 Calibrator Recall (2026-03-16), and Roche cobas pro integrated solutions recall (2026-01-20).
How to tell if you have this one
Check for the model number 99990000 and serial numbers starting with CA or CA0000 (e.g., CA100077, CA000055). The device was sold with specific serial numbers listed in the recall notice.
Brand
Thermo Fisher
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Verify your Cascadion SM Clinical Analyzer's model number and serial number against the list provided in the recall notice.
Where it went and when
Where it was distributed
Distributed in Texas, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “U.S.: Texas O.U.S.: Belgium, France, Germany, Italy, Spain, Switzerland and United Kingdom” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Texas.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1202-2021 (February 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1202-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.