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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 Siemens Ltd Diagnostics Division
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