Sekisui Diagnostics P.E.I. Inc. recalls Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement…

Recall date

November 29, 2016

Source

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

Recall number

Z-1078-2017

FDA classification

Class II

Brand / firm

Sekisui Diagnostics P.E.I. Inc.

Sold / distributed

Worldwide Distribution - US including DE, KS, FL, TX, CA, MI, TN, MA, ID, NJ, RI, IL and Internationally to Austria, Mexico, Canada, India, South Korea, China, Spain, South Korea, and Sri Lanka

Why it was recalled

Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.

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 Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma