Randox Laboratories, Limited: Medical Device Recall in 2019 - (Recall #: Z-2084-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

RX Imola, Model Nos. RX4900

Product Classification:

Class II

Date Initiated: June 24, 2019

Date Posted: July 31, 2019

Recall Number: Z-2084-2019

Event ID: 83175

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.

Status: Terminated

Product Quantity: 27

Code Information:

All serial numbers

Distribution Pattern:

Domestic distribution to CA CT MA MD MO NC NJ NY OH PA UT WV and PR. Worldwide foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated