| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00239-1 |
| Product Name/Description |
Randox Lipase Reagents for use on RX instruments. An in vitro diagnostic medical device (IVD)
Catalogue Numbers: LI7979, LI8050
ARTG Number: 199615
(Randox Australia - Clinical chemistry enzyme IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
Randox have identified that the reagent Triglycerides can cause elevated Lipase results when the Lipase reagent is run after Triglycerides within the same run. This can affect a QC or patient sample test result.
Randox have now released further steps for contamination avoidance with the Lipase assay on RX instruments. Users should refer to the instrument testing order specifically arranging chemistries so that Lipase and Triglycerides are the last two chemistries in the test running order.
In the event of an extremely elevated Lipase result, cuvette maintenance steps should be performed as recommended for each RX system. The sample should then be re-tested running the Lipase assay in isolation. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Randox is advising customers and distributors to amend their test running order and update the RX analyser operator manual with the revised information. Updated IFU's will be provided to users.
In the event of an extremely elevated Lipase result, cuvette maintenance steps should be performed as recommended for each RX system. The sample should then be re-tested running the Lipase assay in isolation.
This action has been closed out on the 20/11/2018. |
| Contact Information |
02 9615 4640 - Randox Australia |