medical Class II Updated 2017-02-01

Sekisui Diagnostics P.E.I. Inc. recalls Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: DE, KS, FL, TX, CA, MI, TN, MA, ID, NJ, RI, IL
Lot/Code Info: Catalog Number: 293-80-91; Lot Numbers: 48737, 48962, 49087, 49220, 49258 and Catalog Numbers: 293-10; Lot Numbers: 48967, 49330, 49331, 49515
View official government recall

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