Drug recall
BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24…
FDA recall event 65619 · Class II · Becton Dickinson & Co.
Key facts
| Event ID | 65619 |
|---|---|
| Recall numbers | Z-1812-2013 |
| Recalling firm | Becton Dickinson & Co. |
| Product type | Devices |
| Products | BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | In vitro diagnostic test kit may exhibit invalid internal negative control results. |
| Initiation date | Jun 13, 2013 |
| Report date | Aug 7, 2013 |
| Termination date | Sep 28, 2013 |
| City | Sparks |
| State | MD |
| Country | United States |
| FEI number | 1119779 |
At a glance
- 1–9 Products in this recall
- 10–99 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: