Randox Laboratories Ltd.: Medical Device Recall in 2021 - (Recall #: Z-2013-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R

Product Classification:

Class II

Date Initiated: April 28, 2021

Date Posted: July 14, 2021

Recall Number: Z-2013-2021

Event ID: 88098

Reason for Recall:

An issue was identified where the software froze during processing of commands, which resulted in no results displayed.

Status: Terminated

Product Quantity: 50 kits

Code Information:

GTIN 05055273206104, Serial Numbers: 7201-0423 7201-0417 7201-0353 7201-0776 7201-0367 7201-0921 7201-0982 7201-0977 7201-0970 7201-0950 7201-0924 7201-0919 7201-0901 7201-0849 7201-0827 7201-0799 7201-0801 7201-0768 7201-0606 7201-0562 7201-0535 7201-0531 7201-0381 7201-0112 7201-0231 7201-0275 7201-0299 7201-0319 7201-0343 7201-0348 7201-0391 7201-0514 7201-0515 7201-0540 7201-0605 7201-0616 7201-0840 7201-0533 7201-0932 7201-0943 7201-0513 7201-0482 7201-0960 7201-0882 7201-0434 7201-0607 7201-0768 7201-0961 7201-0980 7201-0994

Distribution Pattern:

US Nationwide Distribution and Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated