Randox Laboratories: Medical Device Recall in 2018 - (Recall #: Z-2059-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.

Product Classification:

Class II

Date Initiated: May 4, 2018

Date Posted: June 13, 2018

Recall Number: Z-2059-2018

Event ID: 79968

Reason for Recall:

Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.

Status: Terminated

Product Quantity: 41 analyzers

Code Information:

GTIN 05055273206104. All serial numbers.

Distribution Pattern:

US Distribution including Puerto Rico and the state of : West Virginia.

Voluntary or Mandated:

Voluntary: Firm initiated