| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00269-1 |
| Product Name/Description |
ADVIA Chemistry Systems Lipase Assay
Catalogue Number: B01-4840-01, REF: 01984894
Siemens Material Number: 10311896
All lot number affected
ARTG Number: 176331 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has identified the potential for positive biase of ADVIA Chemistry Systems Lipase assay results due to carry-over from one or more of the following tests:
· Triglycerides,
· Triglycerides _2,
· Triglycerides Concentrated,
· Cholesterol Concentrated, and
· Direct LDL reagents.
The carryover potential from these reagents is mitigated by setup of designated contamination avoidance protocols. However, in certain circumstances, rare incidences of carryover interference can occur. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is actively investigating this situation in an effort to provide an improved contamination avoidance protocol for the Lipase assay to eliminate high-biased ADVIA Chemistry Systems Lipase assay results. Siemens has provided customers with a work around to mitigate this problem from occurring.
This action has been closed-out on 01/03/2018. |
| Contact Information |
1800 310 300 - Siemens Technical Support Center |