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FDAMarch 23, 2015device

ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Siemens internal investigation confirmed that current contamination avoidance settings do not prevent carryover resulting in falsely elevated ADVIA Chemistry Lipase outlier results when running with Triglycerides, Triglycerides_2, Triglycerides_c, Cholesterol concentrated, and DLDL reagents.

What to do

FDA enforcement status: Terminated

Brands named

siemens healthcare diagnosticssiemenssiemens healthcare

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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