Drug recall
VITROS XT3400 Chemistry System, Product code 6844458
FDA recall event 86096 · Class II · Ortho Clinical Diagnostics
Key facts
| Event ID | 86096 |
|---|---|
| Recall numbers | Z-2878-2020, Z-2879-2020 |
| Recalling firm | Ortho Clinical Diagnostics |
| Product type | Devices |
| Products | VITROS XT3400 Chemistry System, Product code 6844458, VITROS XT7600 Integrated System, Product code 6844461 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results. |
| Initiation date | Jul 20, 2020 |
| Report date | Sep 2, 2020 |
| Termination date | Dec 18, 2023 |
| 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: