Z-2084-2019 Class II Terminated

Recalled by Randox Laboratories, Limited — Crumlin, N/A

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
27

Product Description

RX Imola, Model Nos. RX4900

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