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U.S. Department of Health and Human Services

Class 2 Device Recall BD CD64 APCR700

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  Class 2 Device Recall BD CD64 APCR700 see related information
Date Initiated by Firm October 30, 2015
Create Date November 24, 2015
Recall Status1 Terminated 3 on May 27, 2016
Recall Number Z-0334-2016
Recall Event ID 72548
Product Classification Reagents,specific,analyte - Product Code MVU
Product 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.
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. 
Recalling Firm/
Manufacturer		 Becton, Dickinson and Company, BD Biosciences
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information Contact Melissa J. Quinn
408-954-6080
Manufacturer Reason
for Recall		 Three lots of CD64 (MD22) are contaminated with CD4 antibody.
FDA Determined
Cause 2		 Process control
Action Urgent Product Recall letters were sent out on October 30, 2015 via certified mail to notify customers of the issue.
Quantity in Commerce 23 vials
Distribution Distributed in the states of FL, WA, PA, IL, GA, RI, TX, ND, and IA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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