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U.S. Department of Health and Human Services

Class 2 Device Recall RX Daytona

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  Class 2 Device Recall RX Daytona see related information
Date Initiated by Firm June 24, 2019
Create Date July 25, 2019
Recall Status1 Terminated 3 on May 21, 2020
Recall Number Z-2083-2019
Recall Event ID 83175
510(K)Number K131554  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product RX Daytona, Model Nos. RX4040 and RX4041
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Randox Laboratories, Limited
Ardmore; 55 The Diamond Road
Crumlin United Kingdom
Manufacturer Reason
for Recall		 There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument.
FDA Determined
Cause 2		 Under Investigation by firm
Action On June 24, 2019, the firm notified its customers of the recall through an Urgent Field Safety Notice. Customers were asked to take the following actions: If there is any sign of damage to the RCU lid or lid sensor " Switch of main analyser main power supply as soon as possible " Contact technical support immediately. " Discuss the contents of this notice with your Medical Director. " Display this notice in a prominent location near the instrument. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days.
Quantity in Commerce 3
Distribution Domestic distribution to CA CT MA MD MO NC NJ NY OH PA UT WV and PR. Worldwide foreign distribution.
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 = JJE and Original Applicant = RANDOX LABORATORIES, LTD.
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