Device 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.
Z-1631-2018
Product summary
- Event
- Event 79767
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8
- Official record key
device-enforcement:Z-1631-2018
Official wording
Reason: Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.
Code information: Lot numbers: 428000, 404175, and 404245
Distribution pattern: US Nationwide Distribution in the states of West Virginia and Puerto Rico
Derived failure modes
-
Unknown
Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.