Reported Jul 14, 2021 · Terminated

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

Randox Laboratories Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Randox Laboratories Ltd. · 55 Diamond Road · Crumlin (North) · N/A

Is this the product you have?

    • Randox RX Imola Analyser with ISE
    • Catalog Numbers RX4900
    • RX4900R
Lot codes and dates
  • 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
Amount recalled
50 kits

Where it was sold

  • Nationwide
  • PR

Why it was recalled

An issue was identified where the software froze during processing of commands, which resulted in no results displayed.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 3, 2021 · Data as of Sep 19, 5:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.