Drug recall
VITROS 250AT Chemistry System, clinical chemistry analyzer
FDA recall event 83322 · Class II · Ortho Clinical Diagnostics
Key facts
| Event ID | 83322 |
|---|---|
| Recall numbers | Z-2174-2019, Z-2175-2019, Z-2176-2019, Z-2177-2019, Z-2178-2019, Z-2179-2019, Z-2180-2019, Z-2181-2019, Z-2182-2019, Z-2183-2019, Z-2184-2019, Z-2185-2019 |
| Recalling firm | Ortho Clinical Diagnostics |
| Product type | Devices |
| Products | VITROS 250AT Chemistry System, clinical chemistry analyzer, VITROS 250 Chemistry System, clinical chemistry analyzer, VITROS 350 Chemistry System, clinical chemistry analyzer, VITROS 4600 Chemistry System, clinical chemistry analyzer, VITROS 5,1 FS Chemistry System, clinical chemistry analyzer and 2 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System |
| Initiation date | Jul 8, 2019 |
| Report date | Aug 14, 2019 |
| Termination date | Oct 19, 2023 |
| City | Rochester |
| State | NY |
| Country | United States |
| FEI number | 1000136573 |
At a glance
- 10–99 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: