Drug recall
VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator…
FDA recall event 92440 · Class II · Ortho-Clinical Diagnostics
Key facts
| Event ID | 92440 |
|---|---|
| Recall numbers | Z-2129-2023 |
| Recalling firm | Ortho-Clinical Diagnostics |
| Product type | Devices |
| Products | VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the highest bias… |
| Initiation date | May 8, 2023 |
| Report date | Jul 19, 2023 |
| City | Rochester |
| State | NY |
| Country | United States |
| FEI number | 1000305841 |
At a glance
- 1–9 Products in this recall
- 1–9 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: