VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the labo
FDA device recall Z-1854-2012 · posted 2012-06-21 · Terminated
Recall details
- Recalling firm
- Accumetrics Inc
- 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
- Action taken
- 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.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- JOZ
- Quantity affected
- 1,167 units total
- Distribution
- US Nationwide Distribution
- Date initiated
- 2012-02-06
- Date posted
- 2012-06-21
- Date terminated
- 2012-11-27
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERIFYNOW-P2Y12 ASSAY (K051231) | Accumetrics, Inc. | 2005-08-05 |