FDA-Device2018-11-14Class II
Liquid Cardiac Control, CQ5051
Randox Laboratories Ltd.
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.
Sold states
Distributed to IN, NY, PR, and WV.
Affected count
1763
Manufactured in
55 Diamond Road, Crumlin (North), Ireland
Products
Liquid Cardiac Control, CQ5051
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0380-2019Don't want to check this manually?
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