Thermo Fisher Scientific: Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910

Is my product affected?

Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910

• UPC 06438153004925

Check against the official notice below — it lists the full affected range.

What happened

Thermo Fisher Scientific is recalling the Cascadion SM Clinical Analyzer (Model 99990000) due to a software defect that can cause the system to report false Vitamin D results under certain assay parameters. The analyzer may fail to quantitate the correct analyte peak in a sample chromatogram, resulting in readings that indicate severe Vitamin D deficiency when this severe deficiency may not actually be present. A total of 19 systems are affected by this recall: 1 system distributed in Texas and 18 systems distributed outside the U.S. in Belgium, France, Germany, Italy, Spain, Switzerland, and the United Kingdom.

The recall affects specific serial numbers of the analyzer, including CA100077, CA000055, CA100073, CA100074, CA000051, CA100062, CA100065, CA100069, CA100070, CA100063, CA000042, CA100071, CA100060, CA100059, CA000058, CA000053, CA000056, CA100061, and CA100066. The source document does not specify what remedy or corrective action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: 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. Distribution: U.S.: Texas O.U.S.: Belgium, France, Germany, Italy, Spain, Switzerland and United Kingdom Quantity: 19 systems (1 system in U.S. and 10 system O.U.S.) Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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