Sekisui Diagnostics Ammonia L3K Assay recall — FDA Z-1078-2017
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.
Overview of recall records associated with Sekisui Diagnostics P.E.I. Inc., including dates, categories and classifications where available.
Classification mix: Class II: 2.
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.
Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover
This page summarizes recall records in which the official source identifies Sekisui Diagnostics P.E.I. Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.