Menarini Silicon Biosystems recalls CELLSEARCH Circulating Tumor Cell Kits (Product Code 7900001) due to potential delays in reporting results from high image counts. Affected kits may require extra time for review.
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.
Menarini Silicon Biosystems is recalling CELLSEARCH Circulating Tumor Cell Kits (Product Code 7900001) because unusually high numbers of images can cause delays in reporting results. This affects medical labs using the kits for cancer testing.
The kits can generate unusually high numbers of images that require additional time for the operator to review. This may delay reporting results to healthcare providers, but does not cause physical harm or injury.
Medical labs that use the CELLSEARCH Circulating Tumor Cell Kits for cancer testing are most affected. Patients receiving these tests may experience delayed results due to the recall.
Check for the Product Code 7900001 on the kit label. The kits were distributed with serial numbers starting with S038R through S038V.
Look for the Product Code 7900001 and serial numbers S038R through S038V on the kit label.
The recall is due to unusually high numbers of images that may require additional time for review, potentially delaying results reporting.
Check the kit label for the Product Code 7900001 and serial numbers S038R through S038V. If affected, contact the manufacturer for guidance.
No, the hazard does not involve physical injury or death. The issue is a potential delay in reporting results.
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-1530-2018 — Menarini Silicon Biosystems Menarini Silicon Biosystems Hello, I own a Menarini Silicon Biosystems that is covered by recall Z-1530-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
