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Sekisui Diagnostics P.E.I Recalls
2 recalls on record · March 23, 2016 to February 1, 2017 · Medical Devices
Recalls by year
16
17
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 1, 2017Medical DevicesFDA
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
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.
March 23, 2016Medical DevicesFDA
Sekisui Diagnostics P.E.I. Inc. recalls Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml
Hazard: Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover