FDA-Device2019-11-27Class II
Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.
Randox Laboratories, Limited
Hazard
Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots.
Sold states
US Distribution: WV, CA, DE, NJ, NY, GA, IN, PR OUS Distribution: CA, PL, CH, JP, NL, IT, CN, GB, IE, RU, MD, BY, SA, VN, AE, BH, DK, CO, ES, FR, TW, PH, TH, OM, HU, IN, KR, ZA, AU, CZ, PE, CL, IR, NZ, BE, DE, BA, SV, SK, HK, PT, PK, BR, TR, UA, SE, QA, LT, PE,
Affected count
6,702
Manufactured in
Ardmore; 55 The Diamond Road, N/A, Crumlin, N/A, United Kingdom
Products
Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0414-2020Don't want to check this manually?
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