RX Daytona Plus Clinical Chemistry Analyzer Rerun Settings Malfunction
Randox Laboratories is recalling the RX Daytona Plus (without ISE) IVD Clinical Chemistry Analyzer due to a flaw in rerun settings that may cause incorrect test result reporting.
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 for a clinical chemistry analyzer with potential for incorrect test result reporting. No illnesses or injuries have been reported. As a risk-of-harm product where injury has not yet been reported, it meets the rubric criterion for High severity.
Plain-English summary
Randox Laboratories Ltd. is recalling the RX Daytona Plus (without ISE)-IVD Clinical Chemistry Analyzer, models RX4041 and RX4041R (refurbished). A total of 6 units were distributed nationwide in the United States, including Puerto Rico.
The recall addresses a malfunction in the analyzer's parameter rerun settings for sample volume and dilutions. When samples fall outside the assay range, the auto-rerun feature may not function correctly, potentially resulting in incorrect test result reporting.
Users of affected units should contact Randox Laboratories Ltd. or the FDA for instructions. Affected lot numbers are: RX4041 (7241-0616, 7241-0582, 7241-0441, 7241-0425, 7241-0384) and RX4041R (7241-0149).
The recalled product
- Product
- RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
- Manufacturer
- Randox Laboratories Ltd.
- Category
- Medical Device
- Affected units
- 6
Distribution
Part of a larger recall action
This product is one of 5 recalled by Randox Laboratories Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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