CELLSEARCH Circulating Tumor Cell Kit recall
CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45…
Why was CELLSEARCH Circulating Tumor Cell Kit 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: (01)10888385000016(17)221004(10)S108 Lot Number: S108 Exp. Date: 04Oct2022
- Product
- CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45…
- Recalling firm
- Menarini Silicon Biosystems
- Quantity
- 484 units
- Distribution
- CA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore,
- Recall date
- July 13, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)