CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of
Summary
The FDA issued a Class II for CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumerat by Menarini Silicon Biosystems. Reason: High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gal.
Details
Source
Device Recall
External ID
Z-1345-2022
Action Date
2022-07-13
Status
Ongoing
Category
device
Product 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
Lot/Code Info: UDI-DI: (01)10888385000016(17)221004(10)S108 Lot Number: S108 Exp. Date: 04Oct2022
Quantity Affected: 484 units
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
Distribution
CA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore,
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-20
Company
Huntingdon Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 120 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Menarini Silicon Biosystems) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Menarini Silicon Biosystems have FDA actions?
This is the only FDA action we have on record for Menarini Silicon Biosystems in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1345-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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