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FDAOctober 2, 2018device

Liquid Cardiac Control, CQ5051

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

randox laboratoriesrandox

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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