Randox RX Daytona Medical Device Recalled for Sensor Malfunction and Heat Damage
Randox Laboratories is recalling RX Daytona instruments due to a sensor malfunction that caused internal wire melting and scorch damage.
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: The recall involves a risk-of-harm product (medical device) where physical damage (melting/scorching) occurred, but no injuries or illnesses have been reported, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Randox Laboratories, Limited is recalling the RX Daytona, Model Nos. RX4040 and RX4041. The recall involves three units distributed domestically to California, Connecticut, Massachusetts, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Utah, West Virginia, and Puerto Rico, as well as worldwide foreign distribution.
The recall was initiated following a report of a sensor malfunction. This malfunction resulted in an increase in temperature, which led to the melting of internal wires and scorch damage to the internal structure of the instrument.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices. No illnesses or injuries are reported in the provided text.
The recalled product
- Product
- RX Daytona, Model Nos. RX4040 and RX4041
- Manufacturer
- Randox Laboratories, Limited
- Hazard
- Affected units
- 3
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)
- All serial numbers
Distribution
Part of a larger recall action
This product is one of 2 recalled by Randox Laboratories, Limited 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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