Randox RX Imola Analyzers Recalled for Software Termination Issue
Randox Laboratories is recalling 41 RX Imola analyzers because a software defect may cause premature termination, delaying patient test results.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a delay in reporting test results due to software termination, with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Randox Laboratories is recalling 41 units of the RX Imola (RX4900) analyzer. These devices are used for professional in vitro determination of various clinical chemistry tests. The recall involves all serial numbers associated with GTIN 05055273206104.
The recall is due to a software defect that may cause abnormal premature termination. This issue could affect the use of the analyzer when running patient samples, resulting in a delay in reporting test results. No injuries or illnesses have been reported in the source text.
The affected units were distributed in the United States, including Puerto Rico and the state of West Virginia. Users of these devices should contact Randox Laboratories for instructions on how to address the software issue.
The recalled product
- Product
- RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
- Manufacturer
- Randox Laboratories
- Affected units
- 41
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. All serial numbers.
Distribution
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