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Recall Observatory FDA recall evidence

Device 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.

Z-1171-2016

January 22, 2016

Class II

Product summary

Firm
Sekisui Diagnostics P.E.I. Inc.
Event
Event 73129
Status
Terminated
Classification
Class II
Quantity
14,407 kits.
Official record key
device-enforcement:Z-1171-2016

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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