Class 2 Device Recall CELLSEARCH Circulating Tumor Cell Kit (Epithelial)

• Date Initiated by Firm: May 20, 2022
• Create Date: July 07, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1345-2022
• Recall Event ID: 90417
• 510(K)Number: K103502
• Product Classification: System, immunomagnetic, circulating cancer cell, enumeration - Product Code NQI
• 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
• Code Information: UDI-DI: (01)10888385000016(17)221004(10)S108 Lot Number: S108 Exp. Date: 04Oct2022
• FEI Number: 3004153557
• Recalling Firm/ Manufacturer: Menarini Silicon Biosystems; 3401 Masons Mill Rd Ste 100; Huntingdon Valley PA 19006-3574
• For Additional Information Contact: SAME; 215-830-0777
• Manufacturer 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
• FDA Determined 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 the false positive images shown below or there is any uncertainty regarding these images impacting the patient's outcome from below the cutoff to above the cut-off, the patient sample should be repeated. Report any previous occurrence of unusually high number of total images/ unassigned events or potential false positive events that have not already been reported to the Customer Technical Support. " Complete and return the enclosed Confirmation of Receipt form no later than May 31, 2022. If you have additional questions about this issue, contact Customer Technical Support at +1-877-837-4339 option 2
• Quantity in Commerce: 484 units
• Distribution: CA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore,
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NQI