Randox RX Imola Analyser with ISE, Catalog Numbers RX4900… recallZ-2013-2021 · Randox Laboratories Ltd. · initiated Apr 28, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Randox Laboratories Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
An issue was identified where the software froze during processing of commands, which resulted in no results displayed.
FDA root cause category: Software design
What the company is doing
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]
Recall details
- Recall number
- Z-2013-2021
- Status
- Terminated
- Initiated by the company
- Apr 28, 2021
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 50 kits
- Product code
- CEM
- Distribution
- US Nationwide Distribution and Puerto Rico.
Product description
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- RX imola RX4900Randox Laboratories Limited · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use3 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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