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Sekisui Diagnostics Llc recalls MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative dete
Recalled July 4, 2012 · FDA recall Z-1902-2012 · Sekisui Diagnostics
Hazard
Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery. · FDA Class II
Units
1600 kits
Sold at
Illinois
Description
Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.
Product
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.
Manufacturer(s)
Sekisui Diagnostics Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →