Randox Laboratories Ltd.: Medical Device Recall in 2018 - (Recall #: Z-2575-2018)

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:

Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.

Product Classification:

Class II

Date Initiated: June 8, 2018

Date Posted: August 8, 2018

Recall Number: Z-2575-2018

Event ID: 80475

Reason for Recall:

The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out of range could lead to a delay in reporting Troponin T results. If the failure occurs the operator may observe the quality control result for Troponin T falling outside range and/or increased imprecision for Quality Control monitoring.

Status: Terminated

Product Quantity: 1 kit (US), 602 kits (OUS)

Code Information:

Lot 4245CK.

Distribution Pattern:

Worldwide Distribution - US in the state of WV. Foreign distribution to Australia, Chile, China, Germany, Hungary, Ireland, Italy, Moldova, Netherlands, Peru, Poland, Saudi Arabia, Slovakia, Spain, Sultanate of Oman, UAE, UK, and Vietnam

Voluntary or Mandated:

Voluntary: Firm initiated