FDA Enforcement
Class II
Terminated
Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
Recall: Z-1002-2015
·
Reported January 28, 2015
Enforcement
- Recall Number
- Z-1002-2015
- Event ID
- 70106
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- BD Biosciences, Systems & Reagents
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 28, 2015
- Initiation Date
- December 19, 2014
- Classification Date
- January 20, 2015
- Termination Date
- March 11, 2016
- Address
- 2350 Qume Dr, N/A, San Jose, CA, 95131-1812, United States
Description
Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
Reason
Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.
Code Info
Lot numbers 4155632 with expiry date of 2015-06-30. Lot 42889687 was not shipped to customers.
Distribution
US Nationwide Distribution in the states of CA, NY, and MI
Quantity
15 units