PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 16, 2018 Initiated: March 2, 2018 #Z-1631-2018

Product Description

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.

Details

Recalling Firm
Randox Laboratories Ltd.
Units Affected
8
Distribution
US Nationwide Distribution in the states of West Virginia and Puerto Rico
Location
Crumlin (North), N/A

Frequently Asked Questions

What product 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.. Recalled by Randox Laboratories Ltd.. Units affected: 8.
Why was this product recalled?
Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 16, 2018. Severity: Moderate. Recall number: Z-1631-2018.