| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00423-1 |
| Product Name/Description |
Lipase Reagent (diagnostic good for the quantitation of lipase in human serum or plasma)
Lot Numbers: 43827UQ12, 43819UQ03, 44449UQ05, 44127UQ06, 44334UQ07, 43994UQ07, 44596UQ08, 44775UQ09, 44930UQ11 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
The Lipase reagent package insert for the lots above has incorrect information regarding the required cuvette SmartWash for Triglyceride. The insert indicates that the Triglyceride cuvette SmartWash assay parameter is not required on ARCHITECT System Software version 7.00 or higher; however, the Triglyceride SmartWash is required for the Lipase assay on all software versions. The insert is correct beginning with lot 45200UQ12. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are advised to verify that Lipase assay parameters on ARCHITECT cSytems are configured for a Trig (Trigylceride) Cuvette SmartWash with 345 volume of 10% Detergent B. If the Lipase SmartWash for Trigylceride is not configured, immediately update the parameter by adding a Trig (Trigylceride) Cuvette SmartWash with 345 volume of 10% Detergent B. Thia action has been closed on 28/01/2016. |
| Contact Information |
1800 816 696 - Abbott Customer Support |