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.
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510(K) Database | 510(K)s with Product Code = JJE
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