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U.S. Department of Health and Human Services

Class 2 Device Recall BD 79b (SN8) phycoerythrin (PE)

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  Class 2 Device Recall BD 79b (SN8) phycoerythrin (PE) see related information
Date Initiated by Firm September 21, 2016
Create Date October 18, 2016
Recall Status1 Terminated 3 on December 27, 2016
Recall Number Z-0128-2017
Recall Event ID 75250
Product Classification Reagents,specific,analyte - Product Code MVU
Product CD79b PE (ASR) , Catalog number 335816 ;

Hematology:
The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig) antigen receptors are composed of a non-covalently associated complex of Ig and two other proteins, Iga and Igb, which have been designated as CD79a and CD79b, respectively.
antigen
Code Information Lot number: 5348570; Expiration Date: 31 July 2017
Recalling Firm/
Manufacturer		 Becton, Dickinson and Company, BD Biosciences
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information Contact Mellissa J/ Quinn
408-954-6307
Manufacturer Reason
for Recall		 CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity
FDA Determined
Cause 2		 Under Investigation by firm
Action BD Life Sciences sent an Urgent Product recall letter dated September 2016 on September 21, 2016 ,to all affected customers via UPS and/or e-mail. Customers were instructed to inspect their inventory to determine if they have any of the affected lots and to discard the affected lots, and BD will issue replacement product. Customers were also instructed to complete the attached Customer Response Form whether or not they have any affected product. Customers needing further assistance should contact BD Customer Support at 855-236-2772 (prompt 3). For customers outside the US, contact their local BD Biosciences representative or distributor. For questions regarding this recall call 408-954-6307.
Quantity in Commerce 14 units
Distribution Nationwide Distribution to CA, MN, OH and TX.
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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