FDA-Device2012-07-04Class II
MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
Sekisui Diagnostics Llc
Hazard
Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.
Sold states
Illinois
Affected count
1600 kits
Manufactured in
31 New York Ave, Framingham, MA, United States
Products
MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1902-2012Don't want to check this manually?
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