Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1202-2021 — Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910

U.S. FDA — Device Enforcement · Finland · 2021-02-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1202-2021
Date of alert
2021-02-01
Country / jurisdiction
Finland
Risk level
Class II
Risk type
recall
Brand
Thermo Fisher Scientific
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
99990000
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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