Cascadion SM Clinical Analyzer recall: Software Issue
Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Why was Cascadion SM Clinical Analyzer recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
- Recalling firm
- Thermo Fisher Scientific
- Quantity
- 19 systems (1 system in U.S. and 10 system O.U.S.)
- Distribution
- U.S.: Texas O.U.S.: Belgium, France, Germany, Italy, Spain, Switzerland and United Kingdom
- Recall date
- March 17, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)