Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Reported: March 17, 2021 Initiated: February 1, 2021 #Z-1202-2021
Product Description
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.
Details
- Recalling Firm
- Thermo Fisher Scientific
- Units Affected
- 19 systems (1 system in U.S. and 10 system O.U.S.)
- Distribution
- U.S.: Texas O.U.S.: Belgium, France, Germany, Italy, Spain, Switzerland and United Kingdom
- Location
- Vantaa
Frequently Asked Questions
What product was recalled? ▼
Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910. Recalled by Thermo Fisher Scientific. Units affected: 19 systems (1 system in U.S. and 10 system O.U.S.).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 17, 2021. Severity: Moderate. Recall number: Z-1202-2021.
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