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Menarini Silicon Biosystems Recalls
2 recalls on record · May 2, 2018 to July 13, 2022 · Medical Devices
Recalls by year
18
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 13, 2022Medical DevicesFDA
Menarini Silicon Biosystems recalls CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of
Hazard: 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
May 2, 2018Medical DevicesFDA
Menarini Silicon Biosystems recalls CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intend
Hazard: Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.