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U.S. Department of Health and Human Services

Class 2 Device Recall Randox RX Imola Analyser with ISE

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 Class 2 Device Recall Randox RX Imola Analyser with ISEsee related information
Date Initiated by FirmApril 28, 2021
Create DateJuly 26, 2021
Recall Status1 Terminated 3 on December 03, 2021
Recall NumberZ-2013-2021
Recall Event ID 88098
Product Classification Electrode, ion specific, potassium - Product Code CEM
ProductRandox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Code Information GTIN 05055273206104, Serial Numbers: 7201-0423 7201-0417 7201-0353 7201-0776 7201-0367 7201-0921 7201-0982 7201-0977 7201-0970 7201-0950 7201-0924 7201-0919 7201-0901 7201-0849 7201-0827 7201-0799 7201-0801 7201-0768 7201-0606 7201-0562 7201-0535 7201-0531 7201-0381 7201-0112 7201-0231 7201-0275 7201-0299 7201-0319 7201-0343 7201-0348 7201-0391 7201-0514 7201-0515 7201-0540 7201-0605 7201-0616 7201-0840 7201-0533 7201-0932 7201-0943 7201-0513 7201-0482 7201-0960 7201-0882 7201-0434 7201-0607 7201-0768 7201-0961 7201-0980 7201-0994 
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		An issue was identified where the software froze during processing of commands, which resulted in no results displayed.
FDA Determined
Cause 2		Software design
ActionUrgent Medical Device Correction letters dated 4/28/21 were sent to customers. Action to be taken: " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. " Please contact your local service provider to arrange for the software update to be performed . "Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation. Please accept our apologies for any inconvenience caused. Thank you for your patience and understanding. If you have any questions or concerns please contact Randox Technical Services. Local Contact Information USA Randox Laboratories-US, Ltd. 515 Industrial Boulevard Kearneysville West Virginia, 25430 Tel: +1 304 728 2890 Toll Free 866 4 RANDOX Email: customersupportusa@randox.com Puerto Rico Clinical Diagnostics of P.R. LLC Carr. 887km 0.6, Carolina Commercial Park Local B-2 Carolina, Puerto Rico Tel: 1-787-701-7000 Email: Jose.Rosario@randox.com
Quantity in Commerce50 kits
DistributionUS Nationwide Distribution and Puerto Rico.
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.
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