Menarini Silicon Biosystems recalls CELLSEARCH Circulating Tumor Cell Kit (Epithelial) due to potential false positive results in cancer cell testing. Affected units have specific part and lot numbers.
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
Menarini Silicon Biosystems is recalling its CELLSEARCH Circulating Tumor Cell Kit (Epithelial) for possible false positive results in cancer testing. This could lead to incorrect cancer diagnoses if used without proper verification.
The kit may generate false positive results due to high numbers of unassigned images in some patient samples. This could lead to incorrect cancer diagnoses if the false positives are not properly verified.
Healthcare professionals using the CELLSEARCH Circulating Tumor Cell Kit for cancer testing are most at risk. Patients receiving results from this kit may be affected by potential false positives.
Check for part number 7900001 and lot number S108 with expiration date 04Oct2022. The kit is intended for use in cancer testing by healthcare professionals.
Verify the part number (7900001) and lot number (S108) with expiration date 04Oct2022.
The recall is for potential false positives, not safety risks. The kit is intended for use in cancer testing by healthcare professionals.
The recall does not specify a remedy, so no action is required beyond checking the kit details.
Look for part number 7900001 and lot number S108 with expiration date 04Oct2022.
We’ve drafted a message you can send Menarini Silicon Biosystems to request your refund or repair — edit it as you like.
Subject: Recall Z-1345-2022 — Menarini Silicon Biosystems Menarini Silicon Biosystems Hello, I own a Menarini Silicon Biosystems that is covered by recall Z-1345-2022 from Menarini Silicon Biosystems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
