Beckman Coulter Inc. recalls Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnosti…

Recall date

July 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3118-2017

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

Distribution US nationwide.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.