Randox Laboratories: Medical Device Recall in 2016 - (Recall #: Z-0762-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T assays on various clinical chemistry and immunoassay systems. This in vitro diagnostic device is intended for prescription use only.

Product Classification:

Class II

Date Initiated: September 16, 2016

Date Posted: December 21, 2016

Recall Number: Z-0762-2017

Event ID: 75262

Reason for Recall:

An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for Randox Immunoturbidimetric and Siemens Centaur Classic methods and CKMB (-21% bias) for Roche e411, BioMerieux Vidas, and Siemens Centaur Classic methods.

Status: Terminated

Product Quantity: 2817

Code Information:

CQ5053 CQ5052

Distribution Pattern:

Worldwide Distribution - US Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated