Recall Z-1375-2015 ยท MVU Reagents, Specific, Analyte
BD Biosciences, Systems & Reagents
CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
| Date | Apr 2, 2015 (initiated Mar 23, 2015) |
| Status | Terminated |
| Reason | One lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody and may result in an unexpected staining pattern. |
| Root cause | Under Investigation by firm |
| Action | Recall letters were sent to affected sites on March 23, 2015 by certified mail. All product in house was placed on ship hold and remaining inventory is in process of being scrapped. |
| Quantity | 9 |
| Distribution | US Distribution in states of: MO, GA, AZ, NE, TX, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.