FDA Device

Liquid Cardiac Control CQ5053

Hazard

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.

What You Should Do

Remedy

A recall notice was issued to customers on August 1, 2017 instructing them to discontinue use of product, discard remaining product for reimbursement and provide documentation of destruction.

Products

Liquid Cardiac Control CQ5053
Brand
Randox Laboratories, Limited Ardmore 55 The Diamond Road Crumlin United Kingdom
UPC
Lot 4069CK

Units Affected

450 kits