Recall Z-1874-2008
Sun Biomedical Laboratories, Inc. · initiated May 28, 2008
Product
VisuaLine Propoxyphene; Propoxyphene test system, intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.
Codes / lots: Sun Biomedical Part #: 15-2017, lot number: Vis-PPX Dip 07-094-1-85.
Reason for recall
Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-1874-2008
- Initiated
- May 28, 2008
- Posted by FDA
- September 17, 2008
- Terminated
- June 10, 2009
- Product code
- JXN – Enzyme Immunoassay, Propoxyphene
- Quantity
- 25 kits
- Distribution
- Class II Recall - Nationwide Distribution --- including states of NJ, TN, LA, GA, AZ, PA, NE, OH, ME, DE, VA, and CT.
- Recalling firm
- Sun Biomedical Laboratories, Inc., Blackwood, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1873-2008 | VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by…Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied. | 05/28/2008Terminated |
| Z-1875-2008 | VisuaLine Tricyclic Antidepressants: Six Dip (COC-THC-OPI-MET-BZD-OXD); Six Dip…Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied. | 05/28/2008Terminated |