Recall Z-1631-2018— Randox Laboratories Ltd.
Class II · Terminated
Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2018-03-02, terminated 2019-04-11. FDA's recall record names no specific 510(k) clearance for this event. 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: Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments..
- Recalling firm
- Randox Laboratories Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-02
- Terminated
- 2019-04-11
- Firm location
- Crumlin (North), N/A, Ireland
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.