Thermo Fisher Recalls Cascadion Clinical Analyzer Due to Software Defect
Thermo Fisher Scientific is recalling 19 Cascadion Clinical Analyzers because a software defect may cause false Vitamin D deficiency results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that could lead to incorrect clinical results (false Vitamin D deficiency), which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Thermo Fisher Scientific is recalling 19 units of the Cascadion SM Clinical Analyzer (REF 99990000, SN Type: 9910) due to a software defect. The recall involves one system in the United States (Texas) and ten systems outside the U.S. (Belgium, France, Germany, Italy, Spain, Switzerland, and the United Kingdom).
The software defect may cause the system to report false Vitamin D results under certain assay parameters. Specifically, the system may fail to quantitate the correct analyte peak in the sample chromatogram, resulting in a reported Vitamin D concentration that indicates severe deficiency in human serum and plasma samples.
Healthcare facilities and users should contact Thermo Fisher Scientific for instructions on how to address the software defect and ensure accurate testing.
The recalled product
- Product
- Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
- Manufacturer
- Thermo Fisher Scientific
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- 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
Distribution
Distributed in 1 state:
Related recalls
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateThermo Fisher Recalls Endura MD Mass Spectrometer Software Due to Data Accuracy Defect
FDA (Devices) · 2016-09-21
- ModerateSiemens Vitamin D Total Assay Recalled for Specimen Correlation Issues
FDA (Devices) · 2016-11-23
- ModerateSiemens ADVIA Centaur Vitamin D Calibrator Recalled for Negative Bias
FDA (Devices) · 2013-04-24
- HighClinical Chemistry Analyzer Recalled for Software Defect in Test Result Calculation
FDA (Devices) · 2025-04-09
- HighRoche Vitamin D Test System Recalled for Falsely Elevated Results
FDA (Devices) · 2018-07-18
- HighSiemens Vitamin D Total Assay Recalled for Plasma Sample Bias
FDA (Devices) · 2016-11-23