Randox Laboratories Ltd. recalls Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: Fo…

Recall date

March 2, 2018

Source

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

Recall number

Z-1631-2018

FDA classification

Class II

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

US Nationwide Distribution in the states of West Virginia and Puerto Rico

Why it was recalled

Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.

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

What was recalled

Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.