Date Initiated by Firm | May 28, 2008 |
Date Posted | September 17, 2008 |
Recall Status1 |
Terminated 3 on June 10, 2009 |
Recall Number | Z-1873-2008 |
Recall Event ID |
48464 |
Product Classification |
Methadone enzyme immunoassay - Product Code DJR
|
Product | VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse. |
Code Information |
Sun Biomedical Part Numbers: 15-2016; Product lot number Vis-OXD-dip 07-018-1-275 or Vis OXD-Dip 07-081-257. |
Recalling Firm/ Manufacturer |
Sun Biomedical Laboratories, Inc. 1001 Lower Landing Rd Blackwood NJ 08012-3124
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For Additional Information Contact | M. Jack Kerins 856-401-1080 |
Manufacturer Reason for Recall | Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied. |
FDA Determined Cause 2 | Other |
Action | On May 29, 2008, Recall Notification Letters were sent via UPS Ground. Each letter had a red label reading "Market Withdrawal Notification on the envelope. Use of the product and distribution was to stop immediately. Returns to be made by UPS and replacement or refund to be issues. If you have any questions contact Jenny Shelton, Sun Biomedical, at 1-888-440-8388. |
Quantity in Commerce | 330 kits of product VIX-OXD-Dip 07-081-1-257; 1 kits of Vix-OXD-07-018-275 |
Distribution | Class II Recall - Nationwide Distribution --- including states of NJ, TN, LA, GA, AZ, PA, NE, OH, ME, DE, VA, and CT. |
Total Product Life Cycle | TPLC Device Report |
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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.
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