FDA-Device2018-03-21Class II
Liquid Cardiac Control CQ5053
Randox Laboratories, Limited
Hazard
Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided control ranges the product is to be recalled from the field.
Sold states
Nationally
Affected count
450 kits
Manufactured in
Ardmore 55 The Diamond Road, Crumlin, United Kingdom
Products
Liquid Cardiac Control CQ5053
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0937-2018Don't want to check this manually?
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