Becton, Dickinson and Company, BD Biosciences: Medical Device Recall in 2015 - (Recall #: Z-0334-2016)

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 CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.

Product Classification:

Class II

Date Initiated: October 30, 2015

Date Posted: December 2, 2015

Recall Number: Z-0334-2016

Event ID: 72548

Reason for Recall:

Three lots of CD64 (MD22) are contaminated with CD4 antibody.

Status: Terminated

Product Quantity: 23 vials

Code Information:

Model 657701; Lot No. 4344945, 5037611, both with expiry date of 31 DEC 2015; and 5063945 with expiry dte of 29 FEB 2016.

Distribution Pattern:

Distributed in the states of FL, WA, PA, IL, GA, RI, TX, ND, and IA.

Voluntary or Mandated:

Voluntary: Firm initiated