FDA-Device2013-06-12Class III

Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits

Bion Enterprises Ltd
Hazard

Affected products have a labeled expiration date of one year too long.

Sold states
Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro)
Affected count
504 units
Manufactured in
455 State St, Suite 100, Des Plaines, IL, United States
Products
Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1479-2013

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