Drug recall
VITROS 3600 Immunodiagnostic System (New and Refurbished)
FDA recall event 93892 · Class II · Ortho-Clinical Diagnostics, Inc.
Key facts
| Event ID | 93892 |
|---|---|
| Recall numbers | Z-1220-2024, Z-1221-2024, Z-1222-2024 |
| Recalling firm | Ortho-Clinical Diagnostics, Inc. |
| Product type | Devices |
| Products | VITROS 3600 Immunodiagnostic System (New and Refurbished), VITROS 5600 Integrated System (New and Refurbished), VITROS XT7600 Integrated System |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to… |
| Initiation date | Jan 22, 2024 |
| Report date | Mar 13, 2024 |
| 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: