Recall – Clinical analyzer software error leads to false results

Company: Thermo Fisher Scientific
Date of Enforcement Report: 3/17/2021
Class II

PRODUCT

Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910

Recall Number: Z-1202-2021

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.

RECALLING FIRM/MANUFACTURER

Thermo Fisher Scientific on 2/1/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

19 systems (1 system in U.S. and 10 system O.U.S.)

DISTRIBUTION

U.S. Nationwide and International

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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