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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
Recalled February 1, 2017 · FDA recall Z-1078-2017 · Sekisui Diagnostics P.E.I
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. · FDA Class II
Units
774 Liters bulk and 565 kits
Sold at
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
Description
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.
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
Manufacturer(s)
Sekisui Diagnostics P.E.I. Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →