Drug recall
VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems…
FDA recall event 66496 · Class II · Ortho-Clinical Diagnostics
Key facts
| Event ID | 66496 |
|---|---|
| Recall numbers | Z-0525-2014 |
| Recalling firm | Ortho-Clinical Diagnostics |
| Product type | Devices |
| Products | VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products CA 125 II Reagent Pack and Calibrators due to a positive shift in patient results. |
| Initiation date | Oct 9, 2013 |
| Report date | Dec 25, 2013 |
| Termination date | May 17, 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: