Class 2 Device Recall VTwin

• Date Initiated by Firm: January 10, 2012
• Create Date: October 16, 2019
• Recall Status: Terminated on April 19, 2024
• Recall Number: Z-0156-2020
• Recall Event ID: 83582
• 510(K)Number: K973628
• Product Classification: Analyzer, chemistry, micro, for clinical use - Product Code JJF
• Product: V-Twin, Catalog # 6002-800, UDI # 03661540600180; ; Product Usage: automated chemistry analyzer intended for clinical use
• Code Information: serial numbers: 10-3331; 10-3332; 11-3301; 11-3304 through 11-3306; 11-3308 through 11-3312; 11-3315; 11-3316; 11-3318 through 11-3342; 12-3302.
• 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: 39 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 = JJF and Original Applicant = VITAL SCIENTIFIC N.V.