Skip to content
Recall Observatory FDA recall evidence

Device product

Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.

Z-3118-2017

July 20, 2017

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 77896
Status
Terminated
Classification
Class II
Quantity
320 units
Official record key
device-enforcement:Z-3118-2017

Official wording

Reason: Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.

Code information: All lots

Distribution pattern: Distribution US nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.