Drug recall
Spectra Optia Apheresis System, Model No. 61000 One Spectra Optia per box (Device is installed at customer…
FDA recall event 83014 · Class III · Terumo BCT, Inc.
Key facts
| Event ID | 83014 |
|---|---|
| Recall numbers | B-0881-2019 |
| Recalling firm | Terumo BCT, Inc. |
| Product type | Biologics |
| Products | Spectra Optia Apheresis System, Model No. 61000 One Spectra Optia per box (Device is installed at customer site) |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | TerumoBCT's Spectra Optia Apheresis System, with the potential for electronic connection intermittency, were distributed. |
| Initiation date | Jun 26, 2019 |
| Report date | Sep 25, 2019 |
| Termination date | Sep 8, 2020 |
| City | Lakewood |
| State | CO |
| Country | United States |
| FEI number | 1000117351 |
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: