FDAClass IIJuly 31, 2019

RX Daytona recall

RX Daytona, Model Nos. RX4040 and RX4041

Why was RX Daytona recalled?

There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All serial numbers

Product
RX Daytona, Model Nos. RX4040 and RX4041
Recalling firm
Randox Laboratories, Limited
Quantity
3
Distribution
Domestic distribution to CA CT MA MD MO NC NJ NY OH PA UT WV and PR. Worldwide foreign distribution.
Recall date
July 31, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls