Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay Recalled by Sekisui Diagnostics P.E.I. Inc. Due to Crystal formation in the Color Reagent (R2) when...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sekisui Diagnostics P.E.I. Inc. directly.
Affected 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.
Quantity: 14,407 kits.
Why Was This Recalled?
Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover
Where Was This Sold?
This product was distributed to 10 states: AZ, CA, FL, ID, IL, IA, MA, MN, MT, ND
About Sekisui Diagnostics P.E.I. Inc.
Sekisui Diagnostics P.E.I. Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report