🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: May 20, 2022 Menarini Silicon Biosystems Infusion Pumps

What Should You Do?

  1. Check if you have this product:
    UDI-DI: (01)10888385000016(17)221004(10)S108 Lot Number: S108 Exp. Date: 04Oct2022
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Menarini Silicon Biosystems
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
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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

Product Codes/Lot Numbers:

UDI-DI: (01)10888385000016(17)221004(10)S108 Lot Number: S108 Exp. Date: 04Oct2022

Distribution:

Distributed in: CA, FL, IL, IN, MA, MI, NC, NM, NY, OH, ON, PA, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1345-2022

Related Recalls

CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.

Menarini Silicon Biosystems

Class I - Dangerous

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.

Apr 4, 2018 Infusion Pumps Nationwide View Details →