FDA-Device2015-04-29Class II
ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
Siemens Healthcare Diagnostics, Inc.
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.
Sold states
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 (S) ,Unit.Arab Emir., Taiwan ,Argentina ,Chile, Malaysia ,Colombia, Peru, Kazakhstan, Paraguay, Vietnam, Algeria, Austria, Belgium, Switzerland, Cyprus, Czech Republic, Germany, Estonia, Spain, Finland, France, United Kingdom, Greece, Hungary, Italy, Lithuania, Luxembourg, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Slovakia and Turkey.
Affected count
7814
Manufactured in
511 Benedict Ave, Tarrytown, NY, United States
Products
ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1457-2015Don't want to check this manually?
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