Drug recall
Elecsys PreciControl Varia 3
FDA recall event 77108 · Class II · Roche Diagnostics Corporation
Key facts
| Event ID | 77108 |
|---|---|
| Recall numbers | Z-2173-2017 |
| Recalling firm | Roche Diagnostics Corporation |
| Product type | Devices |
| Products | Elecsys PreciControl Varia 3 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays |
| Initiation date | Apr 10, 2017 |
| Report date | Jun 7, 2017 |
| Termination date | Aug 4, 2017 |
| City | Indianapolis |
| State | IN |
| Country | United States |
| FEI number | 1823260 |
At a glance
- 1–9 Products in this recall
- None 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: