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U.S. Department of Health and Human Services

Class 2 Device Recall VisuaLine Tricyclic Antidepressants

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  Class 2 Device Recall VisuaLine Tricyclic Antidepressants see related information
Date Initiated by Firm May 28, 2008
Date Posted September 17, 2008
Recall Status1 Terminated 3 on June 10, 2009
Recall Number Z-1875-2008
Recall Event ID 48464
Product Classification Methadone enzyme immunoassay - Product Code DJR
Product VisuaLine Tricyclic Antidepressants:
Six Dip (COC-THC-OPI-MET-BZD-OXD);
Six Dip (COC-THC-OPI-MET-PCP-OXD);
Eight DIP (COC-THC-OPI-MET-AMP-BAR-BZD-OXD);
Nine Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA);
Ten Dip X (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-TCA);
Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-OXD);
Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA-OXD);
Five Dip (COC-THC-OPI-BZD-OXD); and
Six Dip (CPC-THC-OPI-MET-AMP-OXD).

Product is intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.
Code Information Sun Biomedical Part 15-2043; Lot Vis-6SP-Dip 08-021-1; Part 15-2046; lot Vis-6SP-Dip 07-270-1; Part 15-2065, lot Vis-8SP-Dip-07-207-2; Part 15-2072, lot Vis-9SP-Dip-07-106-1; Part 15-2080, lot Vis-10 Dip 06-204-2, Vis-10 Dip 07-002-2, Vis-10-Dip-07-231-1; Part 15-2083, lot Vis-10SP-Dip-07-311-1; Vis-10SP-Dip 07-324-1, VIS 10SP-Dip-08-045-3; Part 15-2085, Lot Vis 10SP Dip-07-201-1, Vis-10SP-Dip 07-263-1; Part 15-2095, lot Vis 5SP-Dip 07-284-2; Vis 5SP-Dip -8-008-01; and Part 15-2101, lot Vis-6SP Dip-07-326-1. 
Recalling Firm/
Manufacturer		 Sun Biomedical Laboratories, Inc.
1001 Lower Landing Rd
Blackwood NJ 08012-3124
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 781 kits
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
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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