Drug recall
BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain…
FDA recall event 72321 · Class III · Becton, Dickinson and Company, BD Biosciences
Key facts
| Event ID | 72321 |
|---|---|
| Recall numbers | Z-0171-2016 |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences |
| Product type | Devices |
| Products | BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text. |
| Initiation date | Sep 30, 2015 |
| Report date | Nov 4, 2015 |
| Termination date | Oct 18, 2016 |
| City | San Jose |
| State | CA |
| Country | United States |
| FEI number | 2916837 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: