Date Initiated by Firm | February 06, 2012 |
Date Posted | June 21, 2012 |
Recall Status1 |
Terminated 3 on November 27, 2012 |
Recall Number | Z-1854-2012 |
Recall Event ID |
61761 |
510(K)Number | K051231 |
Product Classification |
System, automated platelet aggregation - Product Code JOZ
|
Product | 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. |
Code Information |
Not available |
Recalling Firm/ Manufacturer |
Accumetrics Inc 3985 Sorrento Valley Blvd Ste B San Diego CA 92121-1497
|
For Additional Information Contact | 858-404-8247 |
Manufacturer 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 |
FDA Determined Cause 2 | No Marketing Application |
Action | 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. |
Quantity in Commerce | 1,167 units total |
Distribution | US Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = JOZ
|