Class 2 Device Recall

• Date Initiated by Firm: May 10, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on September 07, 2004
• Recall Number: Z-1018-04
• Recall Event ID: 29165
• 510(K)Number: K012701
• Product Classification: System, Automated Platelet Aggregation - Product Code JOZ
• Product: VerifyNow Asprin Assay Kit Part No. 85034
• Code Information: Assay Device Lot WD0034, Kit Lots W17105, W17140.
• FEI Number: 3001376288
• Recalling Firm/ Manufacturer: Accumetrics Inc; 3985 B Sorrento Valley Blvd; San Diego CA 92121
• For Additional Information Contact: Roberta Hoffman; 888-919-9333 Ext. 218
• Manufacturer Reason for Recall: Test results too low in control.
• FDA Determined Cause: Other
• Action: Letters were sent FEDEX on May 10, 2004. Customers were requested to discard the product. Distributors opted to return product. A response form was included to track materials.
• Quantity in Commerce: 4500
• Distribution: Nationwide.
• 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