Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hem
FDA device recall Z-1002-2015 · posted 2015-01-20 · Terminated
Recall details
- Recalling firm
- BD Biosciences, Systems & Reagents
- Reason for recall
- Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.
- Action taken
- BD sent a Recall notification letters dated December, 2014 to affected customers via Certified mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory for affected lots, immediately remove affected reagents from their laboratory, request replacement product and complete and return the enclosed Tracking/Verification form, per the instructions. For questions contact BD Customer Support at 855-236-2772.
- Root cause
- Vendor change control
- Status
- Terminated
- Product code
- MVU
- Quantity affected
- 15 units
- Distribution
- US Nationwide Distribution in the states of CA, NY, and MI
- Date initiated
- 2014-12-19
- Date posted
- 2015-01-20
- Date terminated
- 2016-03-11
- Location
- San Jose, CA
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