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Randox Laboratories Ltd. recalls Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro
Recalled April 1, 2020 · FDA recall Z-1547-2020 · Randox Laboratories
Hazard
The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly. · FDA Class II
Units
186 total, 27 USA
Sold at
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.
Description
The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.
Product
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.
Manufacturer(s)
Randox Laboratories Ltd.
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →