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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1345-2022
Event ID90417
Event DescriptionCELLSEARCH 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 TypeDevices
DistributionCA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore,
Quantity484 units
Recall ReasonHigh 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 Classification20220713
Device Code InfoUDI-DI: (01)10888385000016(17)221004(10)S108 Lot Number: S108 Exp. Date: 04Oct2022
Center Classification Date20220707
Recall Initiation Date20220520
Recalling FirmMenarini Silicon Biosystems
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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