Menarini Silicon Biosystems Recall 90417
Description: 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
Menarini Silicon Biosystems Recall 90417 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1345-2022 |
| Event ID | 90417 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | CA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore, |
| Quantity | 484 units |
| Recall Reason | 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 |
| Device Classification | 20220713 |
| Device Code Info | UDI-DI: (01)10888385000016(17)221004(10)S108 Lot Number: S108 Exp. Date: 04Oct2022 |
| Center Classification Date | 20220707 |
| Recall Initiation Date | 20220520 |
| Recalling Firm | Menarini Silicon Biosystems |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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