[Recalled] 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 blood Part Number: 7900001 —
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | 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 blood Part Number: 7900001 |
|---|---|
| Brand / manufacturer | Menarini Silicon Biosystems |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1345-2022 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 20 May 2022 |
| EAN / barcode | 10888385000016 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Menarini Silicon Biosystems
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.