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U.S. Department of Health and Human Services

Class 2 Device Recall VERIFYNOWP2Y12 ASSAY

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  Class 2 Device Recall VERIFYNOWP2Y12 ASSAY see related information
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 and Original Applicant = ACCUMETRICS, INC.
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