FDA Recall Terminated

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

Recall: Z-0128-2017 · Initiated September 21, 2016

Recall

Recall Number
Z-0128-2017
Event Number
75250
Firm
Becton, Dickinson and Company, BD Biosciences
FEI Number
2916837
Product Code
MVU
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
September 21, 2016
Terminated
December 27, 2016
Address
2350 Qume Dr, San Jose, CA, 95131-1812

Description

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

Reason

CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity

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.

Distribution

Nationwide Distribution to CA, MN, OH and TX.

Quantity

14 units