VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by visual color comparison used for the
FDA device recall Z-1873-2008 · posted 2008-09-17 · Terminated
Recall details
- Recalling firm
- Sun Biomedical Laboratories, Inc.
- Reason for recall
- Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DJR
- Quantity affected
- 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.
- Date initiated
- 2008-05-28
- Date posted
- 2008-09-17
- Date terminated
- 2009-06-10
- Location
- Blackwood, NJ
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