Recall Z-1345-2022 ยท NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Menarini Silicon Biosystems
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
| Date | May 20, 2022 |
| Status | Open, Classified |
| 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 |
| Root cause | Process control |
| Action | Menarini Silicon Biosystems issued notification telephone Urgent Medical Device Correction Notification CTC Kit Lot S108 to US on 5/20/22. Followed by e-mail direct to consignees for US sites - May 23, 2022 and Coordination with Asia Pacific region and the EU with Local QA and RA from the regions. Letter states reason for recall, health risk and action to take: Discontinue usage of Lot S108 and quarantine the lot in your inventory for disposal. Review patient samples run with Kit Lot S108 which had results that were above the cut-off. If you observe any images with the staining pattern of |
| Quantity | 484 units |
| Distribution | CA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103502 | CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 Veridex, LLC, Dec 21, 2010 |