Randox Laboratories Ltd.: Medical Device Recall in 2018 - (Recall #: Z-0381-2019)

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, CQ5052

Product Classification:

Class II

Date Initiated: October 2, 2018

Date Posted: November 14, 2018

Recall Number: Z-0381-2019

Event ID: 81159

Reason for Recall:

Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.

Status: Terminated

Product Quantity: 1738

Code Information:

All lots

Distribution Pattern:

Distributed to IN, NY, PR, and WV.

Voluntary or Mandated:

Voluntary: Firm initiated