Becton, Dickinson and Company, BD Biosciences: Medical Device Recall in 2016 - (Recall #: Z-0628-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.

Product Classification:

Class III

Date Initiated: December 14, 2015

Date Posted: January 20, 2016

Recall Number: Z-0628-2016

Event ID: 72885

Reason for Recall:

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%.

Status: Terminated

Product Quantity: 1,388 units

Code Information:

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

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated