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FDANovember 29, 2016device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

sekisui diagnostics p e isekisuisekisui diagnostics

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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