Randox Laboratories, Limited: Medical Device Recall in 2018 - (Recall #: Z-0937-2018)

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 CQ5053

Product Classification:

Class II

Date Initiated: August 8, 2017

Date Posted: March 21, 2018

Recall Number: Z-0937-2018

Event ID: 79035

Reason for Recall:

Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided control ranges the product is to be recalled from the field.

Status: Terminated

Product Quantity: 450 kits

Code Information:

Lot 4069CK

Distribution Pattern:

Nationally

Voluntary or Mandated:

Voluntary: Firm initiated