Recall Z-0334-2016 ยท MVU Reagents, Specific, Analyte
Becton, Dickinson and Company, BD Biosciences
BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.
| Date | Oct 30, 2015 |
| Status | Terminated |
| Reason | Three lots of CD64 (MD22) are contaminated with CD4 antibody. |
| Root cause | Process control |
| Action | Urgent Product Recall letters were sent out on October 30, 2015 via certified mail to notify customers of the issue. |
| Quantity | 23 vials |
| Distribution | Distributed in the states of FL, WA, PA, IL, GA, RI, TX, ND, and IA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.