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.
FDA Recall Z-0334-2016 · Posted None
Recalling FirmBecton, Dickinson and Company, BD Biosciences
Recall StatusTerminated
Product CodeMVU
Date Initiated2015-10-30
Date Terminated2016-05-27
Product Quantity23 vials
Reason for Recall
Three lots of CD64 (MD22) are contaminated with CD4 antibody.
Firm Action
Urgent Product Recall letters were sent out on October 30, 2015 via certified mail to notify customers of the issue.
Root Cause
Process control
Distribution Pattern
Distributed in the states of FL, WA, PA, IL, GA, RI, TX, ND, and IA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.