Home / Recalls / Sekisui Diagnostics P.E.I. Inc. / Z-1171-2016

Z-1171-2016 Class II Terminated

Recalled by Sekisui Diagnostics P.E.I. Inc. — Charlottetown

Recall Details

Product Type: Devices
Report Date: March 23, 2016
Initiation Date: January 22, 2016
Termination Date: August 9, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14,407 kits.

Product Description

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.

Reason for Recall

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

Distribution Pattern

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.

Code Information

Catalog Number: 506-10 Lot Codes 47677 47694 47649 47650 47662 47663 48253 48385 48386 Catalog Number: 506-30 Lot Codes: 47695 48294