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Sources: EU EUDAMED, US FDA
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FDA Recall
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VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.
FDA Recall
Terminated
·Accumetrics Inc·Product code JOZ·February 6, 2012
VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.
FDA Recall
Terminated
·Accumetrics Inc·Product code JOZ·February 6, 2012
VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests. The VerifyNow IIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow lIb/IlIa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician. The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials. The VerifyNow lIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide.
FDA Recall
Terminated
·Accumetrics Inc·Product code JOZ·November 14, 2013
VerifyNow P2Y12 Assay Device Kit, Part Number 85054
FDA Recall
Terminated
·Accumetrics Inc·Product code JOZ·September 5, 2006
VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials. The VerifyNow IIb/IIIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) IIb/IIIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow Ilb/Illa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.
FDA Recall
Terminated
·Accumetrics Inc·Product code JOZ·February 13, 2014
VerifyNow Asprin Assay Kit Part No. 85034
FDA Recall
Terminated
·Accumetrics Inc·Product code JOZ·May 10, 2004
Accumetrics part number 29001 VerifyNow Instrument, printe power supply
FDA Recall
Terminated
·Accumetrics Inc·Product code JOZ·September 13, 2005
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
FDA Recall
Terminated
·Accriva Diagnostics Inc., dba ITC, dba Accumetrics·Product code JPA·April 22, 2016