Randox Laboratories, Limited recalls Liquid Cardiac Control CQ5053

Recall date

August 8, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0937-2018

FDA classification

Class II

Brand / firm

Randox Laboratories, Limited

Sold / distributed

Nationally

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Liquid Cardiac Control CQ5053