RX Daytona Plus clinical chemistry analyzer may report incorrect test results
The RX Daytona Plus clinical chemistry analyzer may report incorrect results when samples fall outside normal range and the automatic rerun feature malfunctions. Randox Laboratories is recalling 5 units distributed nationwide.
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 a FDA Class II medical device recall involving potential for incorrect test result reporting when samples are outside normal range. This represents a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for High severity.
Plain-English summary
The RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser, Catalog Number RX4040, is being recalled due to defects in its automatic rerun feature. This laboratory instrument is used to analyze clinical chemistry samples.
The device's rerun settings for sample volume levels and automatic dilutions do not properly handle samples that fall above or below the expected assay range. When the device attempts to automatically rerun such samples, it may not meet the correct rerun conditions, potentially resulting in incorrect test result reporting.
The recall affects 5 units with nationwide distribution, including Puerto Rico. The affected lot numbers are 7241-0551, 7241-0545, 7241-0531, 7241-0317, and 7241-0219.
Users of affected devices should contact Randox Laboratories Ltd. to report any suspected issues and determine appropriate steps for device servicing or replacement.
The recalled product
- Product
- RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
- Manufacturer
- Randox Laboratories Ltd.
- Affected units
- 5
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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