Drug recall
enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module…
FDA recall event 75167 · Class II · Ortho-Clinical Diagnostics
Key facts
| Event ID | 75167 |
|---|---|
| Recall numbers | Z-0300-2017 |
| Recalling firm | Ortho-Clinical Diagnostics |
| Product type | Devices |
| Products | enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. --- Thermo Scientific Centrifuge… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Ortho confirmed that it is possible for the mis-association of sample identification and assay results due to an error with Thermo Fisher s centrifuge module. It is possible for mis-associated assay… |
| Initiation date | Sep 7, 2016 |
| Report date | Nov 2, 2016 |
| Termination date | Jun 15, 2018 |
| City | Rochester |
| State | NY |
| Country | United States |
| FEI number | 1000136573 |
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: