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U.S. Department of Health and Human Services

Class 2 Device Recall Viva JR

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  Class 2 Device Recall Viva JR see related information
Date Initiated by Firm January 10, 2012
Create Date October 16, 2019
Recall Status1 Terminated 3 on April 19, 2024
Recall Number Z-0154-2020
Recall Event ID 83582
510(K)Number K973628  
Product Classification Analyzer, chemistry, micro, for clinical use - Product Code JJF
Product Viva - JR, catalog # 6002-940, UDI # 03661540600210

Product Usage: automated chemistry analyzer intended for clinical use
Code Information serial numbers: 11-1302, 11-303, 11-304 , 11-1305
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 2		 Component design/selection
Action The firm reached out to consignees via phone to inform them of the affected product.
Quantity in Commerce 4 units
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.
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