Randox Laboratories Ltd. recalls Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38…

Recall date

March 5, 2024

Source

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

Recall number

Z-1759-2024

FDA classification

Class II

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

Domestic: Nationwide Distribution.

Why it was recalled

Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.

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

What was recalled

Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.