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U.S. Department of Health and Human Services

Class 2 Device Recall RX Imola

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 Class 2 Device Recall RX Imolasee related information
Date Initiated by FirmJune 24, 2019
Create DateJuly 25, 2019
Recall Status1 Terminated 3 on May 21, 2020
Recall NumberZ-2084-2019
Recall Event ID 83175
510(K)NumberK052914 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductRX Imola, Model Nos. RX4900
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
ActionOn 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 Commerce27
DistributionDomestic distribution to CA CT MA MD MO NC NJ NY OH PA UT WV and PR. Worldwide foreign distribution.
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 = JJE
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