Randox Laboratories Ltd. recalls Liquid Cardiac Control, CQ5051

Recall date

October 2, 2018

Source

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

Recall number

Z-0380-2019

FDA classification

Class II

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

Distributed to IN, NY, PR, and WV.

Why it was recalled

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.

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, CQ5051