Class 2 Device Recall VTwin

• Date Initiated by Firm: November 15, 2018
• Create Date: November 22, 2019
• Recall Status: Open, Classified
• Recall Number: Z-0547-2020
• Recall Event ID: 83910
• 510(K)Number: K973628
• Product Classification: Analyzer, chemistry, micro, for clinical use - Product Code JJF
• Product: V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
• Code Information: (OUS) V-Twin¿ 6002-800 serial numbers from 3-3021 till 18-3345; (US) V-Twin¿6002-850 serial numbers from 3-3006 till 9-4037
• Recalling Firm/ Manufacturer: Vital Scientific N.V.; 24, Kanaalweg; Postbus 100; Dieren Netherlands
• For Additional Information Contact: Adriaan Intveld; 435-7526011 Ext. 1487
• Manufacturer Reason for Recall: During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch. If not detected, this may lead to an incorrect patient report.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On November 15, 2018 the firm sent an Urgent Field safety Notice via E-Mail to all affected consignees. The firm also sent out an updated notifications on November 30, 2018 and January 8, 2019 The customer notification addressed the problem and the conditions in which the problem could happen. the urgent field safety notice asked customers to do follow: 1.ELITechGroup is working with the highest priority on a permanent solution to this problem. Pending this permanent fix, we are requesting your cooperation to carry out this mandatory instruction for each active analyzer used. 2.To guarantee a safe operation of the referenced products the following flowchart and instruction must be followed: A. In case PSID is switched off by default; no further action required B. In case non-barcoded sample container are used, disable the PSID in all instances C. In case barcoded sample containers are used and they are positioned by using the PSID functionality or manually assigned a position, please pay attention to a "b" flag or "barcode not scanned" flag. The b-flag may appear with the result if during the run the barcode could not be verified. Whenever a b-flag is present reject the result and repeat the test for the requested sample. 3. Disabling the PSID: A. Please follow the instructions below to disable the internal barcode reader. Disable PSID when non-barcoded sample containers are used. 4. Disabling the System Barcode A. From the Main Menu, Click F5 Special Functions B. Click F2 Installation C. Select System Parameters D. Set Use System barcode to NO 5.. "b-flag" (barcode not scanned): A. Just before sampling the instrument will scan the barcode. When it cannot read the barcode a b-flag will appear with the result. Whenever the b-flag appears, reject the result and repeat the test. 6. Please check the custom automatic evaluation setting for the b-flag in the [Install menu]. For your convenience you can use the custom automatic evaluati
• Quantity in Commerce: 732 instruments
• Distribution: NY
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JJF and Original Applicant = VITAL SCIENTIFIC N.V.