| Class 2 Device Recall BD CD64 APCR700 | |
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
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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 |
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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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