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Sources: EU EUDAMED, US FDA
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FDA Recall
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CellSearch Circulating Tumor Cell Kit (Epithelial) IVD REF 7900001 Veridex LLC, a Johnson & Johnson Company.
FDA Recall
Terminated
·Veridex, LLC·Product code NQI·August 12, 2009
CELLSEARCH 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.
FDA Recall
Terminated
·Menarini Silicon Biosystems·Product code NQI·April 4, 2018
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
FDA Recall
Open, Classified
·Menarini Silicon Biosystems·Product code NQI·May 20, 2022
WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code GEH·March 9, 2015
ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))
FDA Recall
Terminated
·Mindray DS USA, Inc. dba Mindray North America·Product code JGS·December 9, 2019