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U.S. Department of Health and Human Services

Class 2 Device Recall CELLSEARCH Circulating Tunor Cell Kit (Epithelial)

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 Class 2 Device Recall CELLSEARCH Circulating Tunor Cell Kit (Epithelial)see related information
Date Initiated by FirmApril 04, 2018
Create DateApril 26, 2018
Recall Status1 Terminated 3 on April 09, 2019
Recall NumberZ-1530-2018
Recall Event ID 79872
510(K)NumberK103502 
Product Classification System, immunomagnetic, circulating cancer cell, enumeration - Product Code NQI
ProductCELLSEARCH 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.
Code Information UDI (01)10888385000012(17)180810(10)S038 (01)10888385000012(17)180810(10) (01)10888385000012(17)180810(10)S038S (01)10888385000012(17)180810(10)S038T (01)10888385000012(17)180810(10)S038U (01)10888385000012(17)180810(10)S038 V  Serial, Batch, Lot # 2038 S038R S038S S038T S038U S038V S038W (0 distributed to the field)
FEI Number 3004153557
Recalling Firm/
Manufacturer		 Menarini Silicon Biosystems
3401 Masons Mill Rd Ste 100
Huntingdon Valley PA 19006-3574
For Additional Information Contact
215-830-0777
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Process design
ActionMenarini silicon biosystems sent an Urgent Medical Device Correction Notification dated April 3, 2018. Required Actions. " Please dispose of any affected product in your current inventory . " Report any previous occurrence of unusually high number of total images I unassigned events in patient samples to Customer Technical Support. " Complete and return the enclosed Confirmation of Receipt form no later than April 20,2018. For further question, please call (215) 830-0777.
DistributionWorldwide Distribution - USA (nationwide) and to the countries of : Canada and Italy
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NQI
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