FDA-Device2019-06-26Class II
Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
Randox Laboratories Ltd.
Hazard
Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liquid Cardiac Control lots identified, on the Siemens Dimension EXL LOCI.
Sold states
Product distributed to CA, DE, WV, and Puerto Rico.
Affected count
11420 kits
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1785-2019Don't want to check this manually?
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