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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

FDA Recall Z-0128-2017 · Posted None

Recalling FirmBecton, Dickinson and Company, BD Biosciences
Recall StatusTerminated
Product CodeMVU
Date Initiated2016-09-21
Date Terminated2016-12-27
Product Quantity14 units

Reason for Recall

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

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide Distribution to CA, MN, OH and TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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