Randox RX Imola Analyzer Software Freeze Recall - 50 Units Affected
Randox recalls 50 RX Imola Analyser units nationwide and in Puerto Rico due to software freezing that prevents test results from displaying.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with a confirmed software malfunction that prevents critical laboratory test results from displaying. Although no illnesses or injuries have been reported, the defect poses a risk-of-harm to patient care by preventing diagnostic results from being generated.
Plain-English summary
Randox Laboratories Ltd. is recalling the RX Imola Analyser with Integrated Selective Electrode (ISE), catalog numbers RX4900 and RX4900R. The recall affects 50 units with specific serial numbers distributed nationwide throughout the United States and in Puerto Rico.
A software issue has been identified where the analyzer's software freezes during command processing, which results in no test results being displayed to users. This malfunction prevents the device from returning analysis results.
Healthcare facilities and laboratories using these specific units should discontinue use of the affected models and contact Randox Laboratories Ltd. immediately for corrective instructions or replacement options.
The recalled product
- Product
- Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
- Manufacturer
- Randox Laboratories Ltd.
- Affected units
- 50
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN 05055273206104
Distribution
Related recalls
Same manufacturer · Randox Laboratories Ltd.
See all →- ModerateCystatin C Diagnostic Reagent Marketed Without FDA 510(k) Clearance
FDA (Devices) · 2024-07-31
- ModerateEvidence MultiSTAT analyzer foam gasket malfunction may affect test accuracy
FDA (Devices) · 2024-05-15
- HighRandox Clinical Chemistry Calibration Serum Recalled for Measurement Bias
FDA (Devices) · 2024-05-15
- HighMicroalbumin Calibrator Series Recalled for Negative Bias and Patient Result Misclassification
FDA (Devices) · 2024-04-24
- HighMicroalbumin Calibrator Series Recall Due to Measurement Accuracy Issue
FDA (Devices) · 2024-04-24
Same hazard · software malfunction
See all →- HighAbbott Merlin pacemaker programmer may fail to terminate threshold test
FDA (Devices) · 2026-06-17
- HighMedtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
- ModerateProtocol Configuration Tool software v1.3.0 for Hamilton AutoLys STAR
FDA (Devices) · 2026-04-29
- ModerateChange Healthcare Cardiology Hemo Software Unexpected Shutdown Risk
FDA (Devices) · 2025-07-09
- HighSiemens Interventional Fluoroscopic X-Ray System Software Communication Failure
FDA (Devices) · 2025-07-09