Drug recall
VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
FDA recall event 80163 · Class II · Ortho-Clinical Diagnostics
Key facts
| Event ID | 80163 |
|---|---|
| Recall numbers | Z-2344-2018 |
| Recalling firm | Ortho-Clinical Diagnostics |
| Product type | Devices |
| Products | VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control… |
| Initiation date | May 9, 2018 |
| Report date | Jul 11, 2018 |
| Termination date | Aug 18, 2020 |
| 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: