Class 2 Device Recall Selectra ProM analyzer

• Date Initiated by Firm: January 10, 2012
• Create Date: October 16, 2019
• Recall Status: Terminated on April 19, 2024
• Recall Number: Z-0157-2020
• Recall Event ID: 83582
• 510(K)Number: K102647
• Product Classification: Analyzer, chemistry, micro, for clinical use - Product Code JGS
• Product: Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401; ; Product Usage: :clinical chemistry system intended for use in clinical laboratories.
• Code Information: serial numbers: 11-7425; 11-7516; 11-7535; 11-7563; 11-7564.
• Recalling Firm/ Manufacturer: Vital Scientific N.V.; 24, Kanaalweg; Postbus 100; Dieren Netherlands
• Manufacturer Reason for Recall: The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
• FDA Determined Cause: Component design/selection
• Action: The firm reached out to consignees via phone to inform them of the affected product.
• Quantity in Commerce: 5 instruments
• Distribution: US Nationwide in the states of NY, and UT
• 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.

• 510(K) Database: 510(K)s with Product Code = JGS and Original Applicant = ELITECHGROUP VITAL SCIENTIFIC BV