Z-2083-2019 Class II Terminated
FDA device recall Z-2083-2019 was initiated by Randox Laboratories, Limited on June 24, 2019 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated May 21, 2020). Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2019
- Initiation Date
- June 24, 2019
- Termination Date
- May 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
RX Daytona, Model Nos. RX4040 and RX4041
Reason for Recall
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.
Distribution Pattern
Domestic distribution to CA CT MA MD MO NC NJ NY OH PA UT WV and PR. Worldwide foreign distribution.
Code Information
All serial numbers