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.
What this means for you
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:
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