FDA-Device2025-08-13Class II
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Becton, Dickinson and Company, BD Bio Sciences
Hazard
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
Sold states
Worldwide - US Nationwide distribution in the states of Tennessee, New York, Massachusetts and the countries of Argentina, Belgium, Botswana, Brazil, Canada, France, Germany, Lithuania, Peru, Philippines, United Kingdom.
Affected count
10 kits
Manufactured in
155 N Mccarthy Blvd, N/A, Milpitas, CA, United States
Products
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2237-2025Don't want to check this manually?
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