Recall Z-2013-2021 ยท CEM Electrode, Ion Specific, Potassium
Randox Laboratories Ltd.
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
| Date | Apr 28, 2021 |
| Status | Terminated |
| Reason | An issue was identified where the software froze during processing of commands, which resulted in no results displayed. |
| Root cause | Software design |
| Action | 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 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 pati |
| Quantity | 50 kits |
| Distribution | US Nationwide Distribution and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.