Z-0128-2017Class II

CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the...

Name: Z-0128-2017 CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the...
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2016-09-21
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2016-09-21 / Terminated

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I... on 2016-09-21. FDA classified it as Class II and gives the reason as "CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0128-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-21
Posted: 2016-10-18
Terminated: 2016-12-27
Recalling firm: Becton, Dickinson and Company, BD Biosciences
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
Product code: MVU Reagents, Specific, Analyte
Reason for recall: CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity
FDA root cause: 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.
Product codes and lots: Lot number: 5348570; Expiration Date: 31 July 2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0128-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0128-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)