Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Recall
- Recall Number
- Z-2013-2021
- Event Number
- 88098
- Firm
- Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
- FEI Number
- 1000361607
- Product Code
- CEM
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- April 28, 2021
- Terminated
- December 3, 2021
Description
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
An issue was identified where the software froze during processing of commands, which resulted in no results displayed.
Urgent 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 [email protected] 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: [email protected] 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: [email protected]
US Nationwide Distribution and Puerto Rico.
50 kits