Lower riskMedical device recall · FDA · Published April 28, 2021
Randox RX Imola Analyser with ISE: Software freezes causing no results displayed
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.
“Randox RX Imola Analyser with ISE: Software freezes causing no results displayed.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62686-randox-rx-imola-analyser-with-ise-software-freezes-causing-no. Based on FDA recall #Z-2013-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2013-2021%22&limit=1).
The FDA announced on April 28, 2021, that Randox Laboratories Ltd. voluntarily recalled Randox RX Imola Analyzers with ISE due to software freezing during command processing. This issue resulted in no results being displayed to the user.
Distribution: US Nationwide Distribution and Puerto Rico
The hazard
GovInfoNow's records show the hazard involves software freezing during processing of commands, which resulted in no results displayed. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since June 7, 2017. Other recent recalls of similar products include Randox Cystatin C Reagent Recall (June 7, 2024), Randox Evidence MultiSTAT Software v3.7 Recall (April 5, 2024), and Randox Clinical Chemistry Calibration Serum Recall (March 5, 2024).
How to tell if you have this one
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.
Brand
Randox
Product
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Serial Number
Look for serial numbers starting with 7201- on the device label to confirm if it's affected.
Contact Randox for Details
Reach out to Randox Laboratories Ltd. directly for specific guidance on affected units and next steps.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide Distribution and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2013-2021 (April 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2013-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.