Drug recall
cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from…
FDA recall event 64930 · Class II · Roche Molecular Systems, Inc.
Key facts
| Event ID | 64930 |
|---|---|
| Recall numbers | Z-1346-2013 |
| Recalling firm | Roche Molecular Systems, Inc. |
| Product type | Devices |
| Products | cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | In rare instances, channel shifted results have been generated with cobas¿ 4800 assays run on v1.1.1 of the cobas¿ 4800 system. Raw data review indicates that, in these cases, all signals are shifted… |
| Initiation date | Apr 1, 2013 |
| Report date | May 29, 2013 |
| Termination date | Aug 7, 2014 |
| 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: