Drug recall
Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign…
FDA recall event 74982 · Class II · Microgenics Corporation
Key facts
| Event ID | 74982 |
|---|---|
| Recall numbers | Z-0008-2017 |
| Recalling firm | Microgenics Corporation |
| Product type | Devices |
| Products | Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus Assay is intended for the quantitative determination… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A reagent stability issue (still under investigation) causes less separation in the calibration curve, which affects results across the entire range. For controls, maximum bias of +/- 35% for low… |
| Initiation date | Aug 15, 2016 |
| Report date | Oct 12, 2016 |
| Termination date | Jan 4, 2017 |
| City | Fremont |
| State | CA |
| Country | United States |
| FEI number | 3010939897 |
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: