FDA-Device2016-03-23Class II
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.
Sekisui Diagnostics P.E.I. Inc.
Hazard
Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover
Sold states
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.
Affected count
14,407 kits.
Manufactured in
70 Watts Ave, Charlottetown, Canada
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1171-2016Don't want to check this manually?
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