FDA (Devices) recall action 81159
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Randox Laboratories is recalling Liquid Cardiac Control CQ5053 because the product is no longer suitable for controlling the Troponin T assay due to unacceptable variation between vials.
Randox Laboratories is recalling Liquid Cardiac Control CQ5051 because the product is no longer suitable for controlling the Troponin T assay due to unacceptable variation between vials.
Randox Laboratories is recalling Liquid Cardiac Control CQ5052 because the product is no longer suitable for controlling the Troponin T assay due to unacceptable variation between vials.