Randox Laboratories Ltd. recalls Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro…

Recall date

February 18, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1547-2020

FDA classification

Class II

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

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.

Why it was recalled

The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.