FDA recall Z-1631-2018

Product

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-03-02

Report date

2018-05-16

Termination date

2019-04-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1631-2018