Recall Z-0123-2017
Randox Laboratories Ltd. · initiated August 2, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Catalogue number: LI3837, LI7979, LI8050, LI8361
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0123-2017
- Initiated
- August 2, 2016
- Posted by FDA
- October 18, 2016
- Terminated
- September 7, 2017
- Product code
- CDT – Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- Quantity
- 18
- Distribution
- US Nationwide Distribution
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North