Cell Search Circulating Tumor Kit. Intended for the recall
Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
Why was Cell Search Circulating Tumor Kit. Intended for the recalled?
Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples as well as the failure of high control cells.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Part Number 7900001, Kit Lot Number 0074B Exp Date 2015-10-08, Kit Lot Number 0094B Exp Date 2015-12-12
- Product
- Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
- Recalling firm
- Veridex, LLC
- Quantity
- 1560 kits
- Distribution
- Nationwide Distribution.
- Recall date
- August 26, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)