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
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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
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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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