Vantaa, Finland
Thermo Fisher Scientific recalls
1 recall recorded since 2018, most recently on 1 February 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 1 February 2021
- Terminated
- 10 January 2024
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1202-2021
- Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.