Skip to content
Recall Observatory FDA recall evidence

Device product

FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.

Z-0628-2016

December 14, 2015

Class III

Product summary

Firm
Becton, Dickinson and Company, BD Biosciences
Event
Event 72885
Status
Terminated
Classification
Class III
Quantity
1,388 units
Official record key
device-enforcement:Z-0628-2016

Official wording

Reason: 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%.

Code information: Lot No. 4162520, 4206855, 4267919, 4276818, 4309977, 5009530, 5036624, 5085573, 5182818

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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%.