FDA Enforcement
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.
Recall: Z-1631-2018
·
Reported May 16, 2018
Enforcement
- Recall Number
- Z-1631-2018
- Event ID
- 79767
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Randox Laboratories Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 16, 2018
- Initiation Date
- March 2, 2018
- Classification Date
- May 4, 2018
- Termination Date
- April 11, 2019
- Address
- 55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland
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
Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.
Code Info
Lot numbers: 428000, 404175, and 404245
Distribution
US Nationwide Distribution in the states of West Virginia and Puerto Rico
Quantity
8