Recall Z-0128-2017— Becton, Dickinson and Company, BD Biosciences
Class II · Terminated
Class II FDA medical device recall by Becton, Dickinson and Company, BD Biosciences, initiated 2016-09-21, terminated 2016-12-27. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity.
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-21
- Terminated
- 2016-12-27
- Firm location
- San Jose, CA, United States
Product 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 for recall
CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity
Data sourced from openFDA. This site is unofficial and independent of the FDA.