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U.S. Department of Health and Human Services

Class 2 Device Recall Selectra ProM analyzer

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 Class 2 Device Recall Selectra ProM analyzersee related information
Date Initiated by FirmJanuary 10, 2012
Create DateOctober 16, 2019
Recall Status1 Terminated 3 on April 19, 2024
Recall NumberZ-0157-2020
Recall Event ID 83582
510(K)NumberK102647 
Product Classification Analyzer, chemistry, micro, for clinical use - Product Code JGS
ProductSelectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
Code Information serial numbers: 11-7425; 11-7516; 11-7535; 11-7563; 11-7564.
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
ActionThe firm reached out to consignees via phone to inform them of the affected product.
Quantity in Commerce5 instruments
DistributionUS Nationwide in the states of NY, and UT
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JGS
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