Class 2 Device Recall V Twin

• Date Initiated by Firm: September 07, 2018
• Create Date: October 04, 2019
• Recall Status: Terminated on June 29, 2022
• Recall Number: Z-0038-2020
• Recall Event ID: 83648
• 510(K)Number: K973628-A006
• Product Classification: Analyzer, chemistry, micro, for clinical use - Product Code JJF
• Product: V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
• Code Information: The following serial numbers: 14-3301-14-3344; 15-3301-15-3326; 16-3301 -16-3353; 17-3301 -17-3346; 18-3301-18-3323
• Recalling Firm/ Manufacturer: Vital Scientific N.V.; 24, Kanaalweg; Postbus 100; Dieren Netherlands
• Manufacturer Reason for Recall: The action is being initiated because the cooling indicator board was improperly installed. This was first noticed by a service employee during assembly. If for some reason the cooling of the reagent rotor fails, the reagent cooling indicator light will not illuminate and the acoustic beeper will not go off. As a consequence the operator will not be warned and the reagent storage conditions may fall out of specification.
• FDA Determined Cause: Device Design
• Action: On 9/7/2018, a "Medical Device Recall" notice was sent to consignees. The recall notification, informed customers of the following: 1. ELITechGroup B.V. is requesting to correct this issue during the next preventive maintenance visit to your end user. The fix must be applied by a certified service engineer. No spare parts or special tooling is required to fix this issue. When done, this will be the long-term solution. See document 3084-249-00 Instructions Cooling indicator board for the detailed instructions. 2. Short term actions: ELITechGroup B.V. has already amended the applicable assembly and test instructions. No changes to the Service Manual are needed. Long term actions: Through this recall the applicable V-Twin analyzers in the field will be corrected. This action is expected to be finalized in September 2019. 3. For technical questions, please contact System Support department, tel. +31-313-430537 (Monday through Friday, 8:00-17:00 CET), e-mail service.ecsnl@elitechgroup.com On 9/13/2018, a revision to the "Medical Device Recall" notification was sent via email to consignees. The revised notification updated customers on the following issues. 1. Risk to Health: In the event there is no disturbance of the cooling of the reagent rotor the problem will not affect patients, health care providers, or other persons who are exposed to the device. The problem will not cause injuries or delays in treatment. In the event there is  for some reason  a disturbance of the cooling of the reagent rotor and this problem continued to remain undetected, the risk of an incorrect examination result and consequently an incorrect medical treatment and consequently harm to the patient is considered to be very low. Despite a possible failure of the reagent cooling unit, given the claimed on-board stability of the Siemens Healthcare Diagnostics Inc. Syva¿ EMIT¿ System Reagents for use on the V-Twin is typically four weeks, it is possible that all assays will co
• Quantity in Commerce: 192 devices
• Distribution: US Nationwide distribution including the state of New York.
• 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.