Drug recall
CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells…
FDA recall event 90417 · Class II · Menarini Silicon Biosystems
Key facts
| Event ID | 90417 |
|---|---|
| Recall numbers | Z-1345-2022 |
| Recalling firm | Menarini Silicon Biosystems |
| Product type | Devices |
| Products | CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples |
| Initiation date | May 20, 2022 |
| Report date | Jul 13, 2022 |
| City | Huntingdon Valley |
| State | PA |
| Country | United States |
| FEI number | 3004153557 |
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: