Sekisui Diagnostics P.E.I. Inc.: Medical Device Recall in 2016 - (Recall #: Z-1171-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 22, 2016

Date Posted: March 23, 2016

Recall Number: Z-1171-2016

Event ID: 73129

Reason for Recall:

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

Status: Terminated

Product Quantity: 14,407 kits.

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated