Z-1854-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 27, 2012
- Initiation Date
- February 6, 2012
- Termination Date
- November 27, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,167 units total
Product Description
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.
Reason for Recall
The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result whic
Distribution Pattern
US Nationwide Distribution
Code Information
Not available