61 results
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61ms
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Sources: EU EUDAMED, US FDA
BREATHTEK UBT COLLECTION KIT
FDA Adverse Event
Other
·MERETEK DIAGNOSTICS, INC.·Product code MSQ·January 17, 2007
Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 different blood collection tubes (5 each) and 2 different gauge needles--all for drawing blood. One of the tubes is the recalled BD blue top citrate tube (5 tubes). These tubes were manufactured by BD, Franklin Lakes, NJ. The kit is used by health care providers when treating patients.
FDA Enforcement
Class II
·Terminated·Heritage Labs International LLC·April 24, 2013
HooperHolmes Health & Wellness, Product K8303, each kit packed in an envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and instructions. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
Alere Blood Collection Kit (Carolina Care Plan), Product K6900, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
The National Children's Study Adult Blood T3 Mother Kit/Heritage Labs Westat T3 Mother Blood Kit, Product A2015, Kit #BA0146946, each kit packed in a bag or envelope, 25 kits/shipping carton, and contains 2 Triad Medium Alcohol Prep Pads, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code KDT·January 9, 2011
Appraise DBS Test Pak/HW-Kronos KROJI, Product K8603, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and instructions. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
Appraise A1C Test Pak Kit (IBM Care Advantage), Product K7200, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
NDI Combo Test Pak Omega 3, Product K7616, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code KDT·January 9, 2011
The National Children's Study Adult Nail Collection Kit/Heritage Labs Westat Adult Nail Collection Kit, Product A2250, Kit #BJ0136829, and Training Kit, Product A2250T, Kit #TJ0000001, each kit packed in a bag or envelope, 50 kits/shipping carton, and contains 2 Triad Medium Alcohol Prep Pads, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code KDT·January 9, 2011
Rules Based Medicine blood collection kit, Product A1777, each kit packed in a box, 12 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code KDT·January 9, 2011
H & W Research Kit, Product A1776, each kit packed in a bag or envelope. 25 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code KDT·January 9, 2011
Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 different blood collection tubes (5 each) and 2 different gauge needles--all for drawing blood. One of the tubes is the recalled BD blue top citrate tube (5 tubes). These tubes were manufactured by BD, Franklin Lakes, NJ. The kit is used by health care providers when treating patients.
FDA Recall
Terminated
·Heritage Labs International LLC·Product code KST·February 6, 2013
University of Michigan DBS Collection Kit, Product K8306, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and instructions. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
Appraise DBS Test Pak/Moore Medical LLC, Product K8301, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
Heritage Labs DBS/Urine Collection Kit, Product A1101, packed in bags in bulk, 25 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and a form to accompany the specimen . Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
Heritage Labs Appraise Diabetes A1c Test , 24 kits/shipping carton (Product K7604), each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
The National Children's Study Child Hair Kit/Heritage Labs Westat Child Hair Kit, Product A2362, each kit packed in a bag or envelope and contains 2 Triad Medium Alcohol Prep Pads, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies. NOTE: The master carton that went to the customer was misidentified as the Westat Child BNS Saliva Kit but actually contained the Child Hair Kit. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code KDT·January 9, 2011
H & W Principal DBS Collection Kit, Product K8305, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and instructions. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
Reli On Hemoglobin A1c Test (Replacement), Product K7603, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
Appraise A1C Test Pak Kit (Consumers Life Insurance Company), Product K7100, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011