Devices

Device Recall Ammonia L3K Assay

Model / Serial
Catalog Number: 293-80-91; Lot Numbers: 48737, 48962, 49087, 49220, 49258 and Catalog Numbers: 293-10; Lot Numbers: 48967, 49330, 49331, 49515
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
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
Product Description
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
Sekisui Diagnostics P.E.I. Inc.
1 Event
- Recall of Device Recall Ammonia L3K Assay

Manufacturer

Sekisui Diagnostics P.E.I. Inc.

Manufacturer Address
Sekisui Diagnostics P.E.I. Inc., 70 Watts Ave, Charlottetown Canada
Manufacturer Parent Company (2017)
Sekisui Chemical Co. Ltd.
Source
USFDA

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