Drug recall
Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay…
FDA recall event 63140 · Class II · Beckman Coulter Inc.
Key facts
| Event ID | 63140 |
|---|---|
| Recall numbers | Z-0016-2013 |
| Recalling firm | Beckman Coulter Inc. |
| Product type | Devices |
| Products | Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The recall was initiated because Beckman Coulter has confirmed that the Active Renin IRMA Test Kit may exhibit a decrease in stability of the coated tubes. As a result, quality control and patient… |
| Initiation date | Jan 20, 2012 |
| Report date | Oct 17, 2012 |
| Termination date | Oct 5, 2012 |
| City | Brea |
| State | CA |
| Country | United States |
| FEI number | 2050012 |
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: