FDA-Device2012-12-19Class II
BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***
Becton Dickinson & Co.
Hazard
In vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives or misidentification of Hemophilus species present in patient specimens.
Sold states
Worldwide Distribution - USA (nationwide) to international customers in Belgium, India, Japan, South Korea, Thailand and Mexico
Affected count
650 vials
Manufactured in
BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, United States
Products
BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0523-2013Don't want to check this manually?
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