Drug recall
Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems,, Product is manufactured and…
FDA recall event 65187 · Class II · Microgenics Corporation
Key facts
| Event ID | 65187 |
|---|---|
| Recall numbers | Z-1563-2013 |
| Recalling firm | Microgenics Corporation |
| Product type | Devices |
| Products | Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TBIL) claimed in Thermo Scientific MAS Bilirubin Systems are displaying reduced stability. |
| Initiation date | May 13, 2013 |
| Report date | Jul 3, 2013 |
| Termination date | Aug 27, 2013 |
| City | Fremont |
| State | CA |
| Country | United States |
| FEI number | 3005304572 |
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: