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Recall Observatory FDA recall evidence

Device 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

Z-0128-2017

September 21, 2016

Class II

Product summary

Firm
Becton, Dickinson and Company, BD Biosciences
Event
Event 75250
Status
Terminated
Classification
Class II
Quantity
14 units
Official record key
device-enforcement:Z-0128-2017

Official wording

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

Code information: Lot number: 5348570; Expiration Date: 31 July 2017

Distribution pattern: Nationwide Distribution to CA, MN, OH and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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