Drug recall
Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for…
FDA recall event 77260 · Class II · Exact Sciences Corporation
Key facts
| Event ID | 77260 |
|---|---|
| Recall numbers | Z-2219-2017 |
| Recalling firm | Exact Sciences Corporation |
| Product type | Devices |
| Products | Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a Sample Container as part of pre-analytic sample processing for… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Exact Sciences is correcting all Sample Mixer v2 Upgrade units because of incidents of Sample Mixer door damage, which has occurred when the Sample Holder opens during a run and the Sample Holder lid… |
| Initiation date | Apr 28, 2017 |
| Report date | Jun 7, 2017 |
| Termination date | Aug 11, 2017 |
| City | Madison |
| State | WI |
| Country | United States |
| FEI number | 3008256118 |
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: