Drug recall
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
FDA recall event 89183 · Class II · Ortho-Clinical Diagnostics, Inc.
Key facts
| Event ID | 89183 |
|---|---|
| Recall numbers | Z-0503-2022 |
| Recalling firm | Ortho-Clinical Diagnostics, Inc. |
| Product type | Devices |
| Products | VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190. |
| Initiation date | Nov 22, 2021 |
| Report date | Jan 26, 2022 |
| 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: