Recall Z-1854-2012
Accumetrics Inc · initiated February 6, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Not available
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: No Marketing Application
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.
Details
- Recall number
- Z-1854-2012
- Initiated
- February 6, 2012
- Posted by FDA
- June 21, 2012
- Terminated
- November 27, 2012
- Product code
- JOZ – System, Automated Platelet Aggregation
- Quantity
- 1,167 units total
- Distribution
- US Nationwide Distribution
- Recalling firm
- Accumetrics Inc, San Diego, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1853-2012 Class II | VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The…The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically… | 02/06/2012Terminated |