Recall Z-1002-2015 ยท MVU Reagents, Specific, Analyte
BD Biosciences, Systems & Reagents
Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
| Date | Jan 20, 2015 (initiated Dec 19, 2014) |
| Status | Terminated |
| Reason | Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody. |
| Root cause | Vendor change control |
| Action | 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. |
| Quantity | 15 units |
| Distribution | US Nationwide Distribution in the states of CA, NY, and MI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.