Date Initiated by Firm |
January 10, 2012 |
Create Date |
October 16, 2019 |
Recall Status1 |
Terminated 3 on April 19, 2024 |
Recall Number |
Z-0157-2020 |
Recall Event ID |
83582 |
510(K)Number |
K102647
|
Product Classification |
Analyzer, chemistry, micro, for clinical use - Product Code JGS
|
Product |
Selectra 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 |
Action |
The firm reached out to consignees via phone to inform them of the affected product. |
Quantity in Commerce |
5 instruments |
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 = JGS and Original Applicant = ELITECHGROUP VITAL SCIENTIFIC BV
|