Reported Mar 17, 2021 · Terminated
Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Thermo Fisher Scientific
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Thermo Fisher Scientific · Ratashe 2 · Vantaa · N/A
Is this the product you have?
- Cascadion SM Clinical Analyzer
- REF 99990000 SN Type9910
- Lot codes and dates
- Model Number 99990000 GTIN06438153004925
- Serial Numbers
CA100077CA000055CA100073CA100074CA000051CA100062CA100065CA100069CA100070 CA100063 CA000042CA100071 CA100060CA100059CA000058CA000053CA000056CA100061CA100066
- Amount recalled
- 19 systems (1 system in U.S. and 10 system O.U.S.)
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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