Reported Jul 13, 2022 · Ongoing
CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of…
Menarini Silicon Biosystems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Menarini Silicon Biosystems · 3401 Masons Mill Rd Ste 100 · Huntingdon Valley, PA · 19006-3574
Is this the product you have?
- 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 Number7900001
- Lot codes and dates
- UDI-DI(01)10888385000016(17)221004(10)S108
- Lot NumberS108 Exp
- Date04Oct2022
- Amount recalled
- 484 units
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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