FDA Enforcement
Class II
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
Recall: Z-0128-2017
·
Reported October 26, 2016
Enforcement
- Recall Number
- Z-0128-2017
- Event ID
- 75250
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Becton, Dickinson and Company, BD Biosciences
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 26, 2016
- Initiation Date
- September 21, 2016
- Classification Date
- October 18, 2016
- Termination Date
- December 27, 2016
- Address
- 2350 Qume Dr, N/A, San Jose, CA, 95131-1812, United States
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
CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity
Code Info
Lot number: 5348570; Expiration Date: 31 July 2017
Distribution
Nationwide Distribution to CA, MN, OH and TX.
Quantity
14 units