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U.S. Department of Health and Human Services

Class 2 Device Recall VerifyNow IIb/IIIa Test, 10Test Kit

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 Class 2 Recall
VerifyNow IIb/IIIa Test, 10Test Kit
see related information
Date Posted December 11, 2013
Recall Status1 Terminated on December 23, 2013
Recall Number Z-0482-2014
Recall Event ID 66834
Premarket Notification
510(K) Numbers
K011337  K013596  K042423  K051231  K992531 
Product Classification System, Automated Platelet Aggregation - Product Code JOZ
Product VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests. The VerifyNow IIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow lIb/IlIa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician. 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 lIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide.
Code Information Lot No. WC0181H, WC0181J, WC0181K
Recalling Firm/
Manufacturer
Accumetrics Inc
3985 Sorrento Valley Blvd Ste B
San Diego, California 92121-1497
Manufacturer Reason
for Recall
Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information for the amount of time in which to perform the test following collection of the patient sample. The correct instruction is to perform the test within 15 minutes of collecting the patient sample.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action Accumetrics sent an Urgent Medical Device Correction letter dated November 14, 2013 to end users for the VerifyNow IIb/IIIa 10-Test. The letter informs the customers of the problems identified and the actions to be taken. The customers are instructed to call Accumetrics Customer Support at (800) 643-1640 option 2 or email at support@accumetrics.com. Customers are instructed to complete and return the enclosed Customer Account Tracking Form as soon as possible. For questions regarding this recall call 858-643-1600.
Quantity in Commerce 69 units
Distribution Nationwide Distribution including NY, PA, DC, CT, IN, NJ, AR, TX, AZ,and NM.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JOZ and Original Applicant = ACCUMETRICS, INC.
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