Randox recalls RX Imola Analyser with ISE models RX4900/RX4900R due to software freezing during command processing, resulting in no test results. Affected units have specific serial numbers and catalog codes.
An issue was identified where the software froze during processing of commands, which resulted in no results displayed.
Randox is recalling its RX Imola Analyser with ISE (models RX4900 and RX4900R) because software freezes during test processing, meaning no results are displayed. This could lead to inaccurate testing if the device is used without proper results.
The software freezes when processing certain commands, causing the device to stop displaying test results. This means labs might not get accurate or complete test outcomes, potentially affecting medical decisions.
Laboratories and healthcare facilities using the Randox RX Imola Analyser with ISE for medical testing are most affected. The risk is low as the issue only affects test results, not physical safety.
Check for catalog numbers RX4900 or RX4900R on the device label. Serial numbers listed in the recall include 7201-0423 through 7201-0994. The device may also have a GTIN code 05055273206104.
Look for serial numbers starting with 7201- on the device label to confirm if it's affected.
Reach out to Randox Laboratories Ltd. directly for specific guidance on affected units and next steps.
The software freezes during command processing, resulting in no test results being displayed. This could lead to inaccurate testing if the device is used without proper results.
Check for catalog numbers RX4900 or RX4900R and serial numbers starting with 7201- (e.g., 7201-0423 through 7201-0994).
Contact Randox Laboratories Ltd. directly for specific guidance on affected units and next steps.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2013-2021 — Randox Randox Hello, I own a Randox that is covered by recall Z-2013-2021 from Randox. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
