Recall Z-1631-2018 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Randox Laboratories Ltd.
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.
| Date | Mar 2, 2018 |
| Status | Terminated |
| Reason | Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments. |
| Root cause | Under Investigation by firm |
| Action | On March 1, 2018 Randox Laboratories Ltd. sent a Urgent Medical Device Correction Notification to affected customers. These customers were instructed to: 1) Update the user manual for the RX Instrument with the attached technical bulletin; 2) Replace the Instructions for Use contained within the kit with the revised version; 3) Discuss the contents of this notice with your Medical Director; 4) Complete and return the vigilance response section of this form to technical.services@randox..com within five working days; 5) Send a copy of the FSN to all affected customers and to those who need to be |
| Quantity | 8 |
| Distribution | US Nationwide Distribution in the states of West Virginia and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.