Drug recall
Automated Bloodborne Pathogen Test Equipment: Roche Diagnostics cobas 6800 System, Material Number…
FDA recall event 83156 · Class III · Roche Molecular Systems, Inc.
Key facts
| Event ID | 83156 |
|---|---|
| Recall numbers | B-0668-2019 |
| Recalling firm | Roche Molecular Systems, Inc. |
| Product type | Biologics |
| Products | Automated Bloodborne Pathogen Test Equipment: Roche Diagnostics cobas 6800 System, Material Number: 05524245001; Roche Diagnostics cobas 8800 System- Material Number: 05412722001 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Cobas (6800 & 8800) systems, with a potential for leakage from the processing transfer heads, were distributed. |
| Initiation date | Jun 11, 2019 |
| Report date | Aug 21, 2019 |
| Termination date | Jul 7, 2021 |
| City | Branchburg |
| State | NJ |
| Country | United States |
| FEI number | 2243471 |
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: