U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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.
조치
Accumetrics, Inc. sent an Urgent Field Correction notification letter and an Ackknowledgement - fax back form to all affected customers. The letter identifed the affected product, problem and actions to be taken. The letter informed customers that an Accumetrics representative will be
contacting them to schedule an appointment to update their VerifyNow
instrument software. The letter stated that Accumetrics realizes that procedures and report format may need to be revised as software changes is implemented, and will provide assistance to help in making this transition. For any questions or concerns, call at 1-800-643-1640 ext. 2; or
email at: support@accumetrics.com.
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.