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U.S. Department of Health and Human Services

Class 2 Device Recall VTwin

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  Class 2 Device Recall VTwin see related information
Date Initiated by Firm January 18, 2016
Create Date September 23, 2019
Recall Status1 Open3, Classified
Recall Number Z-2558-2019
Recall Event ID 83607
510(K)Number K973628  
Product Classification Analyzer, chemistry, micro, for clinical use - Product Code JJF
Product V-Twin, Model # 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 Serial #s: 13-3341 and 13-3344
Recalling Firm/
Manufacturer		 Vital Scientific N.V.
24, Kanaalweg
Postbus 100
Dieren Netherlands
Manufacturer Reason
for Recall		 Instrument stopped working due to a software lockup, and no patient results are produced.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action In very close cooperation with the consignees, the affected end users running on EPROM version V1.2.3 were contacted. Initially, a temporary work around (reset of the software) was communicated with the consignees. The consignees devices were installed to document all errors during runtime .In addition, a new software was developed and tested. The new software resulted in version 1.2.5 of EPROM, which was released June 23, 2016. Consignees of the V-Twin all received a field update kit with the new software.
Quantity in Commerce 2
Distribution US in 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 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.
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