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U.S. Department of Health and Human Services

Class 2 Device Recall VerifyNow IIb/IIIa Test

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  Class 2 Device Recall VerifyNow IIb/IIIa Test see related information
Date Initiated by Firm February 13, 2014
Date Posted March 11, 2014
Recall Status1 Terminated 3 on August 23, 2014
Recall Number Z-1172-2014
Recall Event ID 67508
510(K)Number K992531  K011337  K013596  
Product Classification System, automated platelet aggregation - Product Code JOZ
Product VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit.

Product Usage:
The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials. The VerifyNow IIb/IIIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) IIb/IIIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow Ilb/Illa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.
Code Information Lot/Serial No.  WC0182B, WC0182C, WC0182A, WC0182D, WC0182E, WC0182F, WC0182G, WC0180C, WC0180E, WC0180F, WC0181A, WC0181C, WC0181D, WC0181F, WC0180A, WC0180B, WC0180D, WC0181B, WC0181E, WC0181G, WC0181H, WC0181J, WC0181K.
Recalling Firm/
Manufacturer		 Accumetrics Inc
3985 Sorrento Valley Blvd Ste B
San Diego CA 92121-1497
For Additional Information Contact
858-643-1600
Manufacturer Reason
for Recall		 Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous low platelet aggregation unit (PAU) result. An erroneous low PAU result may cause a low percent inhibition calculation or low baseline PAU.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Accumetrics sent an Urgent Medical Device Recall letter dated February 13, 2014 to all affected customers. The recall letter informs the customers of the problems identified and the actions to be taken. Cusotomers are instructed to complete the attached Customer Account Tracking Form and return it within 10 days by fax, email or mail. Customers with questions are instructed call Accumetrics Customer Support at (800) 643-1640 option 2 or email at support@accumetrics.com.
Quantity in Commerce 576 units total (524 units in US)
Distribution USA 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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