FDA-Device2017-09-20Class II
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
Beckman Coulter Inc.
Hazard
Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.
Sold states
Distribution US nationwide.
Affected count
320 units
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3118-2017Don't want to check this manually?
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