Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.

Recall date

March 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1457-2015

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Worldwide Distribution - US (nationwide) Distribution and to the countries of : Thailand, Pakistan, Vatican, Guadeloupe, Reunion, French Polynesia , Serbia, Martinique, India, China, Singapore, Brazil, South Africa, Mexico, Canada, Israel, Australia, Egypt, Russian Federation, Indonesia, Rep. Korea…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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