Beckman Coulter Inc. recalls Beckman Coulter, Lipase Assay, Catalog No. OSR6X30

Recall date

December 15, 2014

Source

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

Recall number

Z-1023-2015

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

Nationwide in US and Puerto Rico. World Wide: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyrus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritr…

Why it was recalled

N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. NAC interference may lead to falsely low results.

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

What was recalled

Beckman Coulter, Lipase Assay, Catalog No. OSR6X30