Recall Z-1000-2015 ยท GKL Counter, Cell, Automated (Particle Counter)
BD Biosciences, Systems & Reagents
CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.
| Date | Jan 20, 2015 (initiated Dec 19, 2014) |
| Status | Terminated |
| Reason | One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data. |
| Root cause | Process control |
| Action | Recall notification letters were sent to all consignees on December 19, 2014 by certified mail. |
| Quantity | 165 units |
| Distribution | Worldwide distribution. US Nationwide including Puerto Rico, China, Brazil, Japan, Guatemala, India, New Zealand, Australia, Canada, Thailand, Chile and Malaysia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904390 | ANTI-HUMAN LEU-2A (CD8) PE Bd Becton Dickinson Vacutainer Systems Preanalytic, Dec 17, 1990 |