Randox RX Daytona Plus Clinical Chemistry Analyzer Software Recall
Randox Laboratories is recalling RX Daytona Plus clinical chemistry analyzers to fix software issues causing incorrect sample ordering and quality control flags.
What this means for you
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, but the issues are software display errors (sample ordering and QC flagging) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Randox Laboratories, Limited is recalling the RX Daytona Plus clinical chemistry analyzer, specifically models RX4040 (with ISE) and RX4041 (without ISE). The recall involves 5 units distributed nationwide in the United States, including Puerto Rico. The affected units are equipped with software version UI2550642107.
The recall is initiated to correct two specific software issues: the order of samples displayed is not sequential according to the sample identification number (SID) when searching the run/results screen, and there is incorrect color flagging of internal quality control (IQC) as "out of range." The agency has classified this as a Class II recall.
Clinical laboratories using these analyzers should contact Randox Laboratories to obtain the updated software version that resolves these display and flagging errors. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories.
- Manufacturer
- Randox Laboratories, Limited
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)
- Software version UI2550642107 for the RX Daytona Plus instrument.
Distribution
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