Class 3 Device Recall VerifyNow

• Date Initiated by Firm: September 13, 2005
• Date Posted: October 28, 2005
• Recall Status: Terminated on March 03, 2007
• Recall Number: Z-0102-06
• Recall Event ID: 33691
• 510(K)Number: K992531
• Product Classification: System, Automated Platelet Aggregation - Product Code JOZ
• Product: Accumetrics part number 29001 VerifyNow Instrument, printe power supply
• Code Information: lot number G-13850
• FEI Number: 3001376288
• Recalling Firm/ Manufacturer: Accumetrics Inc; 3985 B Sorrento Valley Blvd; San Diego CA 92121
• For Additional Information Contact: Roberta G. Hoffman; 888-919-9333 Ext. 218
• Manufacturer Reason for Recall: In 2001, separate reports of mild shock, sparking and smoke from Accumetrics PN 29001 power supply.
• FDA Determined Cause: Other
• Action: Letters and replacement power supplies were sent to consignees by Fedex, 2-day with proof of delivery. End-user customers were instructed to return the affected power supply to Accumetrics, using the provided pre-paid shipping carton. Consignees who do not return the power supply within two weeks of the notification will be contacted by phone to assess compliance with the recall and to determine the status of the product at the site.
• Quantity in Commerce: 11
• Distribution: CA, FL, IL, LA, NH, NV, NY, OK, WA
• 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