Devices

Device Recall Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K Assay

Model / Serial
Catalog Number: 506-10 Lot Codes 47677 47694 47649 47650 47662 47663 48253 48385 48386 Catalog Number: 506-30 Lot Codes: 47695 48294
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, IA, ID, IL, MA, , MN, MT and ND., and to the countries of Canada, France and Hong Kong.
Product Description
Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic || Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml || Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml || In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.
Manufacturer
Sekisui Diagnostics P.E.I. Inc.
1 Event
- Recall of Device Recall Sekisui Diagnostics Sekure Chemistry Acetaminophen 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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