Becton, Dickinson and Company, BD Biosciences: Medical Device Recall in 2015 - (Recall #: Z-0171-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.

Product Classification:

Class III

Date Initiated: September 30, 2015

Date Posted: November 4, 2015

Recall Number: Z-0171-2016

Event ID: 72321

Reason for Recall:

Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.

Status: Terminated

Product Quantity: 120 units

Code Information:

Catalog Number: 349201; Lot Number 5148598 (expires 10-31-2016) Catalog Number: 340542; Lot Number 5113983 (expires 02-28-2017)

Distribution Pattern:

US (nationwide) Distribution to the states of : TX, GA, IN, TN, CA, KY, WA, IL, MO, NY, CT, MN, NV, KS, WI, NH, FL, PA, OH, OR, SC. OK, NC and LA., and Internationally to Mexico.

Voluntary or Mandated:

Voluntary: Firm initiated