Z-2013-2021Class II

Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R

Name: Z-2013-2021 Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Creator: Randox Laboratories Ltd.
Published: 2021-04-28
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2021-04-28 / Terminated / root cause: software

FDA source

Randox Laboratories Ltd. began a recall of Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R on 2021-04-28. FDA classified it as Class II and gives the reason as "An issue was identified where the software froze during processing of commands, which resulted in no results displayed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2013-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-28
Posted: 2021-07-26
Terminated: 2021-12-03
Recalling firm: Randox Laboratories, Limited
Product: Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Product code: CEM Electrode, Ion Specific, Potassium
Reason for recall: An issue was identified where the software froze during processing of commands, which resulted in no results displayed.
Root cause tag: software
FDA 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 [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]
Quantity in commerce: 50 kits
Distribution: US Nationwide Distribution and Puerto Rico.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2013-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2013-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-14	2021-07-06

Product code CEM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)