FDA-Device2020-04-01Class II
Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.
Randox Laboratories Ltd.
Hazard
The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.
Sold states
Worldwide distribution - US Nationwide distribution in the states of WV, IN, VA, ID, PR, DE, and countries of West Indies, Czech Republic, France, Germany, Hong Kong, Ireland, Italy, Norway, Philippines, South Africa, South Korea, Sweden, Taiwan (R.O.C.), Thailand, UAE, UK.
Affected count
186 total, 27 USA
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1547-2020Don't want to check this manually?
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