Recall Z-1875-2008 ยท DJR Enzyme Immunoassay, Methadone
Sun Biomedical Laboratories, Inc.
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
| Date | Sep 17, 2008 (initiated May 28, 2008) |
| Status | Terminated |
| Reason | Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied. |
| Root cause | 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 | 781 kits |
| Distribution | Class II Recall - Nationwide Distribution --- including states of NJ, TN, LA, GA, AZ, PA, NE, OH, ME, DE, VA, and CT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.