Recall Z-0123-2017 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Randox Laboratories Ltd.
Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in 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.
| Date | Oct 18, 2016 (initiated Aug 2, 2016) |
| Status | Terminated |
| Reason | According to the firm carry over was observed when the Lipase test is run directly before or after the LDL and Triglycerides assays. Customers are instructed to amend the running order for all instruments using these reagents to ensure Lipase is not place directly before or after LDL or Triglycerides. A correction was made to the IFU for the Lipase assay and all customers who purchased the Lipase kit in the USA were contacted with the updated instruction. |
| Root cause | Nonconforming Material/Component |
| Action | Randex Laboratories sent an Urgent Field Safety Notice letter dated June 17, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the response section of this form technical.services@randox.com. For questions contact Randex Technical Service. |
| Quantity | 18 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.