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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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