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Sources: EU EUDAMED, US FDA
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PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90110, 100 test kit (obsolete), manufactured by DiaDexus, South San Francisco, CA.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·October 29, 2009
diaDexus PLAC Test ELISA Kit; Manufactured and distributed by diaDexus , Inc., South San Francisco, CA; Model Part Number: 90123 The diaDexusPLAC Test ELISA Kit is an enzyme Immunoassay for the quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) in human plasma and serum, to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary hear disease, and ischemic stroke associated with atherosclerosis.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·March 15, 2010
PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90112, 50 test kit, manufactured by DiaDexus, South San Francisco, CA.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·October 29, 2009
PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90107, 100 test kit, manufactured by DiaDexus, South San Francisco, CA.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·October 29, 2009
PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90115, Beckman test kit, manufactured by DiaDexus, South San Francisco, CA.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·October 29, 2009
PLAC Test Calibrator Kit, Five-level liquid calibrator set for use with the diaDexus PLAC Test Reagent Kit, assembled in a kit box with an outer label, Catalog numbers 90108 and 10-0108, manufactured by diaDexus inc., South San Francisco, CA. Intended to establish points of reference that are used in the determination of values in the determination of Lp-PLA2 by the PLAC Test Reagent Kit.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·February 9, 2009
PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in human plasma or serum. Product consists of a liquid, ready to use, two reagent kit assembled in a kit box.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·July 18, 2008
PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 10-112, 10-0113, and 10-115 Advia test kit, manufactured by DiaDexus, South San Francisco, CA.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·October 29, 2009
diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum, liquid ready-to-use two-reagent kit assembled in a kit box, manufactured by diaDexus Inc, South San Francisco, CA 94080, Catalog number 90110 Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum on automated clinical chemistry analyzers, to be used in conjunction with clinical evaluations and patient risk assessment as an aide in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·November 4, 2008
diaDexus PLAC Test ELISA Kit, Enzyme Immunoassay for Quantitative Determination of Lp-PLA2 in human plasma or serum, part number 90123, manufactured by diaDexus Inc, South San Francisco.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·August 20, 2010
PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90116, 250 test kit, manufactured by DiaDexus, South San Francisco, CA.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·October 29, 2009
PLAC Test ELISA kit, catalog number 90106, enzyme immunoassay for the quantitative determination of Lp-PLA2 in human plasma and serum, kit containing coated microwell stripplate and reagents (12 strips, 1 set calibrators 1 to 6, 0.25 ml each, 20x wash buffer, 50 mL, conjugate 23 mL, TMB, 11 mL, Stop solution, 11 mL
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·July 18, 2008
V-CATH Insertion Kits, Sterile; Product Code Number: 301-00; Manufactured by Centurion Medical Products for Neo Medical; 42514 Albrae Street, Fremont, CA 94538
FDA Recall
Terminated
·Neo Medical, Inc.·Product code LRS·April 5, 2011
Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
FDA Recall
Terminated
·NEO METRICS, INC.·Product code OCY·March 31, 2014
Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
FDA Recall
Terminated
·Cook Inc.·Product code KOE·January 4, 2019
SpF PLUS-Mini (60 A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code LOE·February 19, 2018
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
FDA Recall
Terminated
·EBI Patient Care, Inc.·Product code LOE·April 20, 2017
EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code LOE·February 19, 2018
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
FDA Recall
Terminated
·EBI Patient Care, Inc.·Product code LOE·April 20, 2017
Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710.
FDA Recall
Terminated
·Cook Urological, Inc.·Product code KOE·August 1, 2005