Class 2 Device Recall Cascadion SM Clinical Analyzer

• Date Initiated by Firm: February 01, 2021
• Create Date: March 10, 2021
• Recall Status: Terminated on January 10, 2024
• Recall Number: Z-1202-2021
• Recall Event ID: 87309
• Product Classification: Mass spectrometer, clinical use - Product Code DOP
• Product: Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
• Code Information: Model Number 99990000 GTIN: 06438153004925 Serial Numbers: CA100077, CA000055, CA100073, CA100074, CA000051, CA100062, CA100065, CA100069, CA100070 CA100063 CA000042, CA100071 CA100060, CA100059, CA000058, CA000053, CA000056, CA100061, CA100066
• FEI Number: 3007262384
• Recalling Firm/ Manufacturer: Thermo Fisher Scientific; Ratashe 2; Vantaa Finland
• Manufacturer 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.
• FDA Determined Cause: Software design
• Action: On 02/01/2021, the firm sent an "URGENT - MEDICAL DEVICE RECALL" Notification Letter to inform customers that the Recalling Firm has identified that there is a software anomaly in the Analyzer Software subcomponent called Suhaili Service (version 2.0.3 and earlier) that is affecting the Analyzer. Suhaili Service controls raw data processing based on assay configuration data from Sample Prep software. Processed results are sent to Sample Prep software for patient result reporting. This anomaly, as a result of this interface, has a potential risk of reporting wrong patient results for Vitamin D. Customers are informed, As an immediate correction the following instructions must be followed with Cascadion SM Clinical Analyzer Software versions 2.0.2 and earlier until the installation of the new software version 2.1. 1. Please distribute this information immediately to any staff that may be impacted by this issue. 2. Please change the Quick Connect Cartridge Cs on the instrument to new ones. 3. After the cartridge change, if a sample is reported to have concentration of total 25-hydroxy Vitamin D below assay measuring range, follow these instructions to prevent the error from being reported: a. Repeat the sample analysis with a Cascadion SM Clinical Analyzer b. In case the repeated result is below assay measuring range, the sample should be rerun on another assay and platform. 4. Retain a copy of this letter for your laboratory records. 5. As appropriate, contact your Medical Professional for evaluation of further action. 6. Please, fill out the MEDICAL DEVICE RECALL- Response Form and return it within 5 days of the date of this letter to your manufacturer as instructed in the form and as listed: Email: vigilance.clinical.fi@thermofisher.com The actions to be taken by the Recalling Firm: 1. The Recalling Firm has informed the appropriate Regulatory Agencies. 2. When, available, the final corrective action will be to update Clinical Analyzer software v2.1
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.