Recall Z-0128-2017 ยท MVU Reagents, Specific, Analyte
Becton, Dickinson and Company, BD Biosciences
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
| Date | Sep 21, 2016 |
| Status | Terminated |
| Reason | CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity |
| 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 l |
| Quantity | 14 units |
| Distribution | Nationwide Distribution to CA, MN, OH and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.