FDA recall Z-1202-2021

Product

Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910

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

Key facts

Status

Terminated

Initiation date

2021-02-01

Report date

2021-03-17

Termination date

2024-01-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Vantaa, Finland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1202-2021