Device recall
Z-0334-2016: BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945…
FDA device recall · Class II · Becton, Dickinson and Company, BD Biosciences
Key facts
| Recall number (Z-number) | Z-0334-2016 |
|---|---|
| Recall event | 72548 |
| Product | 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. |
| Product code | MVU |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 27, 2016 |
| FEI number | 2916837 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database