Sekisui Diagnostics P.E.I. Inc. recalls Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml,…

Recall date

January 22, 2016

Source

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

Recall number

Z-1171-2016

FDA classification

Class II

Brand / firm

Sekisui Diagnostics P.E.I. Inc.

Sold / distributed

Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, IA, ID, IL, MA, , MN, MT and ND., and to the countries of Canada, France and Hong Kong.

Why it was recalled

Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover

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

What was recalled

Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.