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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
Recalled March 23, 2016 · FDA recall Z-1171-2016 · Sekisui Diagnostics P.E.I
Hazard
Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover · FDA Class II
Units
14,407 kits.
Sold at
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.
Description
Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover
Product
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.
Manufacturer(s)
Sekisui Diagnostics P.E.I. Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →