CLASS II Device recall · Reported 14 Jul 2021 · FDA Enforcement Report
Randox RX Imola Analyser with ISE recalled by Randox Laboratories
Randox Laboratories is recalling Randox RX Imola Analyser with ISE, distributed nationwide in the US. The recall was initiated on 28 Apr 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2013-2021
- FDA event ID
- 88098
- Recalling firm
- Randox Laboratories, Crumlin (North)
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Apr 2021
- FDA classified
- 6 Jul 2021
- Reported
- 14 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 28 Apr 2021 | Recall initiated by company | |
| 6 Jul 2021 | Classified by FDA | +69 days |
| 14 Jul 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An issue was identified where the software froze during processing of commands, which resulted in no results displayed.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Where it was distributed
US Nationwide Distribution and Puerto Rico.
Questions about this recall
Why was it recalled?
An issue was identified where the software froze during processing of commands, which resulted in no results displayed.
Which lots are affected?
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
Where was it sold?
US Nationwide Distribution and Puerto Rico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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