Drug recall
cobas e801 Immunoassay Analyzer
FDA recall event 90657 · Class II · Roche Diagnostics Operations, Inc.
Key facts
| Event ID | 90657 |
|---|---|
| Recall numbers | Z-1515-2022 |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Product type | Devices |
| Products | cobas e801 Immunoassay Analyzer |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin… |
| Initiation date | Jul 14, 2022 |
| Report date | Aug 17, 2022 |
| City | Indianapolis |
| State | IN |
| Country | United States |
| FEI number | 1823260 |
At a glance
- 1–9 Products in this recall
- None 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: