FDAFebruary 1, 2021device
Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 to do
FDA enforcement status: Terminated
Brands named
thermo fisher scientificthermothermo fisher
UPCs
06438153004925
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDABoston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm); REF: CSK-TC15, CSK Electrode, STAINLESS STEEL, 15 cm x 28 ga (0.36 mm); REF: CSK-TC15-3M, CSK Electrode, STA...2026-04-29
- FDABoston Scientific Model SC-4318, Clik X Anchor REF: M365SC431802026-04-29
- CPSCFree-Standing Professional Gas Ranges Recalled Due to Risk of Burn Hazard; Manufactured by Fisher & Paykel2026-04-16
- FDALUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.52026-03-30
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