FDA-Device2016-01-20Class III
FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.
Becton, Dickinson and Company, BD Biosciences
Hazard
Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting functional degradation. The functional degradation has the effect of reducing the percent positive from 100% down to approximately 87%.
Sold states
Nationwide Distribution
Affected count
1,388 units
Manufactured in
2350 Qume Dr, N/A, San Jose, CA, United States
Products
FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0628-2016Don't want to check this manually?
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