Thermo Fisher recalls Cascadion SM Clinical Analyzer (SN 9910) due to software defect causing false Vitamin D results. Affected units may indicate severe Vitamin D deficiency. No remedy specified in recall notice.
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.
Thermo Fisher is recalling specific models of the Cascadion SM Clinical Analyzer because a software defect can cause false Vitamin D results. This may lead to incorrect health assessments and indicate severe Vitamin D deficiency in patients. The recall affects only certain units with specific serial numbers.
The software defect causes the analyzer to misread Vitamin D levels in samples, showing unusually low concentrations that suggest severe deficiency. This could lead to incorrect health decisions if the false results are used for patient care.
Healthcare providers using the Cascadion SM Clinical Analyzer for Vitamin D testing are most at risk. Patients receiving results from affected units may receive inaccurate health assessments.
Check for the model number 99990000 and serial numbers starting with CA or CA0000 (e.g., CA100077, CA000055). The device was sold with specific serial numbers listed in the recall notice.
Verify your Cascadion SM Clinical Analyzer's model number and serial number against the list provided in the recall notice.
The recall is due to a software defect that causes the analyzer to report false Vitamin D results under certain assay conditions.
Patients receiving results from affected units may be incorrectly assessed for severe Vitamin D deficiency.
Check the model number (99990000) and serial numbers starting with CA or CA0000 (e.g., CA100077, CA000055) as listed in the recall notice.
We’ve drafted a message you can send Thermo Fisher to request your refund or repair — edit it as you like.
Subject: Recall Z-1202-2021 — Thermo Fisher Thermo Fisher Hello, I own a Thermo Fisher that is covered by recall Z-1202-2021 from Thermo Fisher. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
