Randox Laboratories Ltd. recalls RX Series Copper (Cu) Assay Ref. Number CU2340

Recall date

November 29, 2023

Source

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

Recall number

Z-0992-2024

FDA classification

Class II

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

US Nationwide distribution in the states of SC and OK.

Why it was recalled

Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results.

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

What was recalled

RX Series Copper (Cu) Assay Ref. Number CU2340